Identity
- Trade Name
- +well EUDAMED
- Device Name
- Disposable probe covers EUDAMEDInfrared Ear Thermometer EUDAMED
- Model / Reference
- IET2PC/IET3PC EUDAMEDIET2PC EUDAMEDET-100D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931562702931 EUDAMED06931562702924 EUDAMED
- Basic UDI-DI
- 69315627ET-01J7 EUDAMEDB-06931562702924 EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMEDV0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Northern Ireland 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
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular booties
+well by Hangzhou Hua'an Medical & Health Instruments Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69315627ET-01J7 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69315627ET-01J7 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013858
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 85ba8003-521a-43db-aa8e-782502d00da9 61 fields · synced Jul 13, 2026
- EUDAMED 6f0c11d0-b36b-48db-b9ac-98cf6f0ddb72 61 fields · synced May 19, 2026