Identity
- Trade Name
- Handheld Pulse Oximeter EUDAMED
- Device Name
- Handheld Pulse Oximeter EUDAMED
- Model / Reference
- YK-820B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921745200613 EUDAMED06921745215020 EUDAMED
- Basic UDI-DI
- 69217452HPO37 EUDAMEDB-06921745215020 EUDAMED
- Direct Marketing DI
- 06921745200613 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPoland 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
Handheld Pulse Oximeter by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69217452HPO37 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69217452HPO37 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 72ddee1e-da47-4a95-971d-b4739a965598 61 fields · synced Oct 6, 2026
- EUDAMED 454ee61b-f1a5-4a8e-a896-ca13ac4dffee 61 fields · synced May 19, 2026