Identity
- Trade Name
- Pulse Oximeter EUDAMEDAccurate® FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- FS20A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06927394555555 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06927394555555 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
- Germany 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Pulse Oximeter by Hunan Accurate Bio-Medical Technology Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-06927394555555 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012835
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 9798fd06-dd3b-4a91-931b-5c0c1ccbea67 61 fields · synced Oct 6, 2026
- FDA UDI 29d0abf9-6f86-4a7d-bd23-1e828d076e23 32 fields · synced May 30, 2026