What a public register can and cannot tell you: four databases and one CE mark

On 17 September 2026 Qure.ai announced that Aira, its clinical decision support system, “has received Class IIb CE certification under the EU Medical Device Regulation (MDR)”. The announcement names no notified body and no certificate number. Recent publishes a regulatory status only on a regulator's record, so the question was practical: which public register would show it? This article reads four sets of registers (the EU's EUDAMED, the US FDA's databases, Australia's ARTG, and Japan's PMDA and Ministry of Health, Labour and Welfare) for what each can and cannot tell a reader. It is product intelligence, not regulatory advice. Every record below was read on 28 September 2026, and each should be read again before anyone relies on it.

Five verbs that are not interchangeable

Regulators use different verbs, and they are not synonyms. The FDA clears a device through a 510(k) when it finds it “substantially equivalent” to a legally marketed device, and grants a De Novo request; neither is an approval. A company registers an establishment with the FDA and lists its devices, and the federal regulation says registration “does not in any way denote approval of the establishment or its products”. In the EU a notified body certifies. Australia's register records a device as included. In Japan, the product is approved after the PMDA's review.

EUDAMED: the device search and the certificate search

Searched by manufacturer on 28 September 2026, EUDAMED's device module lists five devices for Qure.ai Technologies Private Limited of Mumbai, all Class IIb under the MDR and on the market since 14 March 2024: a qSuite entry and the qXR, qER-NCCT, qMSK and qCT modules. None is Aira, and none of the five device records references a certificate. A search for the trade name “Aira” returns no Qure.ai device, and the company's UK entity has no devices listed.

The certificate module shows something the device module does not. It holds an EU quality management system certificate under the MDR, No. G10 106322 0004 Rev. 02, issued on 4 August 2026 by TÜV SÜD Product Service GmbH (notified body 0123) to the same Mumbai company. Its revision history reads “Supplemented: Device(s)/group of device(s) added”, and it lists a Class IIb device group whose intended purpose begins:

Recent analysis: the register does hold a record that corresponds to the company's statement, but in the certificate module rather than the device module. The record is a quality management system certificate, and the notified body states that technical documentation was assessed “for devices selected on a representative basis”. It shows that a notified body certified a quality management system covering a device group whose intended purpose names Aira. It does not show Aira registered as a device, where it is marketed, or how it performs. The headline's “Among World's First” is the company's own description.

Why is the device search empty? Since 28 May 2026 device registration and certificate registration in EUDAMED have been mandatory. According to the Commission services' EUDAMED questions and answers, a device first placed on the EU market after that date must be registered “before the first individual unit is placed on the EU market”, so a certified device not yet on the market need not appear. The same questions and answers, which note that they have not been formally endorsed by the Commission, add that, for certain devices, device data “will become visible to the public only once the NB has entered the corresponding product certificate information”. Absence from the device search is therefore not evidence against a certificate, and here the certificate was on the register.

The reverse also happens. In November 2024 SeqOne said the SeqOne Platform received certification under the IVDR as a Class C device “from the notified body GMED”. EUDAMED's device module now lists the SeqOne Platform as a Class C IVDR device on the market with no certificate referenced, and a certificate search for SeqOne returned nothing. Certificates issued before 28 May 2026 must be registered by 28 May 2027, so for now the notified body named by the company remains the company's statement.

FDA: a listing is not a clearance

The FDA's registration and listing database shows Sword Health S.A. in Porto and SWORD Health, Inc. in Salt Lake City as registered establishments listing “Sword Thrive” and “Digital Therapist” under product code ISD, “Exerciser, Measuring”. The FDA's classification data place ISD in Class II and limit it to the “510(K) Exempt” submission type. The 510(k) database returns no record with Sword as applicant. A listing tells a reader that a company has told the FDA it makes a device of a given type; it is not a 510(k) clearance, and nothing in these records says the FDA reviewed Sword Thrive.

Compare Natural Cycles. The FDA granted its De Novo request, DEN170052, on 10 August 2018, and the 510(k) database holds five later decisions for the product, the most recent on 17 July 2026, each “Substantially Equivalent”. Qure.ai itself appears here too: five qXR records, each “Substantially Equivalent”, from qXR-BT in December 2021 to qXR-Detect in January 2026. None of them says anything about Aira in Europe.

A clearance also has a scope. The decision letter for Hinge Health's Enso for Migraine (K254216, 16 April 2026) finds the device substantially equivalent “for the indications for use stated in the enclosure”, and adds that the determination “does not mean that FDA has made a determination that your device complies with other requirements of the Act”.

ARTG: an inclusion, in the TGA's words

The TGA's public summary for ARTG entry 522634 reads “ARTG entry for Medical Device Included Class 1”, with sponsor Alcidion Aus Pty Ltd and an ARTG start date of 22 January 2026, for “Clinical-coding information system application software”. Its intended purpose names “The Miya Precision Concept Detection” and says that “All detected concepts suggested require the clinician to validate before inclusion in the patient's record.” The summary is explicit about its limits: “This is not an ARTG Certificate document”, and “The onus is on the reader to verify the current accuracy of the information”.

Alcidion's ASX announcement of 19 February 2026 says Concept Detection “has been registered as a Class I Software as a Medical Device (SaMD) on the Australian Register of Therapeutic Goods (ARTG #522634) and with the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)”. The Australian half matches the TGA's record. The MHRA half is the company's statement: Recent has not read the MHRA register, and writes it as Alcidion's.

PMDA and MHLW: an approval with its terms

Japan publishes the review itself. The PMDA's list gives CureApp HT as approved in “April 2022”, with an English review report. The report states the intended use, “Adjunctive treatment of essential hypertension in adults”, and a condition: the applicant “is required to collect post-marketing information on the efficacy of the product annually after approval”. The Ministry's notice of 26 April 2022 gives approval number 30400BZX00100000. Here a reader can quote, in the regulators' words, what the product is approved for and on what terms. The same records are read for what they mean for a product's route to patients in an earlier Journal article.

Recent analysis: a reading order for product teams

First, take the company's exact verb and the exact entity. Second, go to the register that records that verb: a certificate in EUDAMED's certificate module, a clearance in the 510(k) database, an inclusion in the ARTG, an approval in the PMDA's reports. Third, read the scope (device group, indications, intended purpose, conditions), because each record is narrower than the headline that cites it. Fourth, treat an empty search as a question: a register can be empty because of timing, because the wrong module was searched, or because a claim is wrong, and the search alone does not say which. Fifth, date the reading.

Recent writes regulatory status in the regulator's verb and on the regulator's record, and attributes everything else to the company. Aira is a case where reading a second part of the same register changed what can be cited: the certification the company announced now has a regulator-held record beside it, while Aira's device registration and its performance remain open.