Identity
- Trade Name
- Non-Adhesive Wrap EUDAMEDFDA UDI
- Generic Name
- Pulse Co-oximeter probe, reusable FDA UDI
- Device Name
- Multi-Site Attachment Ring EUDAMEDSentec’s Non-Adhesive Wrap is intended to be wrapped around the thigh of neonatal patients with very sensitive/fragile skin for subsequent attachment of Sentec Sensors. Sentec’s Non-Adhesive Wrap is a non-adhesive application ring, single-patient use up to 24 hours, recommended for preterm / neonatal patients. FDA UDI
- Model / Reference
- 103520 EUDAMEDFDA UDI
- Description
- Sentec’s Non-Adhesive Wrap is intended to be wrapped around the thigh of neonatal patients with very sensitive/fragile skin for subsequent attachment of Sentec Sensors. Sentec’s Non-Adhesive Wrap is a non-adhesive application ring, single-patient use up to 24 hours, recommended for preterm / neonatal patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121881039 EUDAMEDFDA UDI
- Basic UDI-DI
- 764012188MARJD EUDAMED
- FDA Product Code
- DPZ FDA UDILPP FDA UDILKD FDA UDIKLK FDA UDIDQA FDA UDI
- EMDN Code
- Z1203020405,Z1203020485 EUDAMED
- GMDN Term
- Pulse Co-oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2710 FDA UDI868.2500 FDA UDI868.2480 FDA UDI870.2700 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
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Non-Adhesive Wrap by SenTec AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764012188MARJD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sentec AG
- EUDAMED SRN
- CH-MF-000008058
- Authorised Representative
- Sentec GmbH DE-AR-000007618
Sources (2)
- EUDAMED bb212eeb-8b27-4f48-99d8-9cddd85b4ca6 61 fields · synced Jul 17, 2026
- FDA UDI 15d903f1-a9d6-4e3d-8f72-d242d36b53a8 35 fields · synced May 30, 2026