Identity
- Trade Name
- Presteril EUDAMED
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- YK-81A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08016867016759 EUDAMED
- Basic UDI-DI
- 69217452FPO2V EUDAMED
- Direct Marketing DI
- 08016867016759 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS 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
Presteril by Xuzhou Yongkang Electronic Science Technology 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 | 69217452FPO2V | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED d91d6732-a9bc-4b15-bcdf-0d030a646e40 61 fields · synced Jun 19, 2026