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Fingertip Oximeter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PC-60ARef POD-1WModel POD-1、POD-1WRef PC-60B1Model PC-60B1、POD-3、PC-60F、PC-60FWRef PC-60BModel PC-60B、POD-2、POD-2W
Identity
- Trade Name
- Fingertip Oximeter EUDAMEDPulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Fingertip Oximeter EUDAMED
- Model / Reference
- PC-60A EUDAMEDFDA UDIPC-60B1 EUDAMEDFDA UDIPC-60B EUDAMEDFDA UDIPOD-1、POD-1W EUDAMEDPOD-1W EUDAMEDPC-60B1、POD-3、PC-60F、PC-60FW EUDAMEDPC-60B、POD-2、POD-2W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941900601468 EUDAMED06941900606401 EUDAMED06941900603691 EUDAMED06941900605459 EUDAMED06941900603202 FDA UDI06941900603028 FDA UDI06941900603011 FDA UDI
- Basic UDI-DI
- B-06941900601468 EUDAMED69419006FOximeter010424 EUDAMED69419006FOximeter0101ZT EUDAMED69419006FOximeter010322 EUDAMED
- Direct Marketing DI
- 06941900606401 EUDAMED06941900603691 EUDAMED06941900605459 EUDAMED
- 510(k) Number
- K063641 FDA UDI
- 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 EUDAMEDNetherlands 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fingertip Oximeter by Shenzhen Creative Industry Co., Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06941900601468 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06941900601468 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000009430
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (7)
- EUDAMED e4fd32cc-132d-4155-ad0e-03cb48975980 61 fields · synced Jul 24, 2026
- FDA UDI 569b35d6-c836-40ac-a147-e13d7759dbe4 33 fields · synced May 29, 2026
- FDA UDI 85598a0e-2da8-4c2e-b6ec-44b54fec2b9e 33 fields · synced May 30, 2026
- FDA UDI 204a5319-a472-4e0e-ad3e-b50a7d7ad85a 33 fields · synced May 30, 2026
- EUDAMED 1c2c3eb4-a06f-44ae-a33c-6deb81a82098 61 fields · synced Jul 9, 2026
- EUDAMED b909413f-3c1a-49a0-b01a-cc51e0aafd74 61 fields · synced Jul 19, 2026
- EUDAMED 2201effc-249d-48fc-9529-b19c716ebd6a 61 fields · synced Jul 24, 2026