Identity
- Trade Name
- Yonker FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Fingertip Pulse Oximeter EUDAMEDThe fingertip pulse oximeter can be used to measure human haemoglobin saturation and pulse rate through finger , it can be used in hospitals, families, schools and medical centers. FDA UDI
- Model / Reference
- YK-81C EUDAMEDFDA UDI
- Description
- The fingertip pulse oximeter can be used to measure human haemoglobin saturation and pulse rate through finger , it can be used in hospitals, families, schools and medical centers. FDA UDI
Identifiers
- Catalog Number
- Fingertip Pulse Oximeter FDA UDI
- Primary DI / UDI-DI
- 06921745201061 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06921745201061 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fingertip Pulse Oximeter by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06921745201061 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 3a54bdc9-5f44-433e-8be7-d139480b77b3 61 fields · synced Oct 6, 2026
- FDA UDI 81c586de-3d64-4410-8f3b-6a1732e268a8 34 fields · synced May 30, 2026