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One Medical
EUDAMEDClass IIa (EU MDR)
Ref ET005Model ET001, ET003, ET005, ET008, ET009, MD-H30, ET101, ET102, ET103, ET106, ET107, ET108
Identity
- Trade Name
- ONE MEDICAL EUDAMED
- Device Name
- Ear Thermometer EUDAMED
- Model / Reference
- ET001, ET003, ET005, ET008, ET009, MD-H30, ET101, ET102, ET103, ET106, ET107, ET108 EUDAMEDET005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770030378222 EUDAMED
- Basic UDI-DI
- 69476561ETXXX54 EUDAMED
- Direct Marketing DI
- 03770030378222 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
One Medical by Guangzhou Berrcom Medical Device Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69476561ETXXX54 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Berrcom Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000013852
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cf90c9cf-8087-4cd6-a291-18f2b1c7ef69 61 fields · synced May 29, 2026