Identity
- Trade Name
- Infrared thermometer EUDAMED
- Device Name
- Infrared thermometer EUDAMED
- Model / Reference
- BK8005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038680053 EUDAMED
- Basic UDI-DI
- 69310386INF001F6 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Infrared thermometer by Wenzhou Bokang Instruments 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 | 69310386INF001F6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wenzhou Bokang Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000021505
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7c067141-8c5d-4815-ba81-a5c947efbe08 61 fields · synced Jun 18, 2026