Identity
- Device Name
- Wrist Oximeter EUDAMED
- Model / Reference
- AP-10、PC-68B EUDAMEDPC-68B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941900606593 EUDAMED
- Basic UDI-DI
- 69419006WOximeter0101PP EUDAMED
- Direct Marketing DI
- 06941900606593 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Wrist Oximeter by Shenzhen Creative Industry 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 | 69419006WOximeter0101PP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000009430
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED e188cf25-3522-47a6-9b1f-b270b1a5b817 61 fields · synced Jun 18, 2026