Identity
- Trade Name
- Spo2 sensor EUDAMEDOrantech FDA UDI
- Generic Name
- Pulse oximeter probe, reprocessed FDA UDI
- Device Name
- Spo2 sensor EUDAMEDGE Datex-Ohmeda Compatible, Adult Finger Clip, 1.0M FDA UDI
- Model / Reference
- SS-011-AF10 EUDAMEDFDA UDI
- Description
- GE Datex-Ohmeda Compatible, Adult Finger Clip, 1.0M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691973775 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06941691973775 EUDAMED
- 510(k) Number
- K181270 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, reprocessed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Denmark 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Spo2 sensor by Orantech Inc. — Class IIb — 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-06941691973775 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED 7431c18f-4f16-4f26-8559-d8e43f2d047f 61 fields · synced May 31, 2026
- FDA UDI 608573be-a928-4db7-9659-43a66ed19785 34 fields · synced May 29, 2026