Identity
- Trade Name
- Fingertip Pulse Oximeter EUDAMED
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- YK-80A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921745200002 EUDAMED
- Basic UDI-DI
- B-06921745200002 EUDAMED69217452FPO2V EUDAMED
- Direct Marketing DI
- 06921745200002 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Fingertip Pulse Oximeter by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06921745200002 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06921745200002 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 342d59a9-d80e-48cd-a6a1-87f49d5ffe6c 61 fields · synced Oct 6, 2026
- EUDAMED 8ca17c65-fed0-4408-b055-ab34a3af1257 61 fields · synced May 19, 2026