Identity
- Trade Name
- Fingertip Pulse Oximeter EUDAMED
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- BP-10M EUDAMED90300146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937683426374 EUDAMED
- Basic UDI-DI
- B-06937683426374 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fingertip Pulse Oximeter by Shenzhen Biocare Bio-Medical Equipment Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06937683426374 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000005653
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c7fdae26-ebe1-4bf0-884f-8c2e2e874e11 61 fields · synced Jul 8, 2026