Identity
- Trade Name
- Pulse Oximeter EUDAMEDAccurate® FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- FS20A EUDAMEDFS10I EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06927394511131 EUDAMEDFDA UDI
- Basic UDI-DI
- 69273945PO01WA EUDAMED
- Direct Marketing DI
- 06927394511131 EUDAMED
- FDA Product Code
- OCH 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
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
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 — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141105 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K171241 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 69273945PO01WA | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69273945PO01WA | Class IIa | Active |
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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 (3)
- EUDAMED a61df2a9-72a0-4556-af29-e85d353a0b05 61 fields · synced Oct 6, 2026
- FDA UDI 1e4c6b1d-d4bc-4f80-9059-782432418393 32 fields · synced May 30, 2026
- FDA 510(k) K141105 1 fields · synced May 18, 2026