Identity
- Trade Name
- Contact Gel EUDAMEDFDA UDI
- Generic Name
- Pulse Co-oximeter probe, reusable FDA UDI
- Device Name
- Contact Gel EUDAMEDThe Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor Membrane. GEL-SD is delivered in single dose vials each containing 0.3 g of the solution and is intended for single use. FDA UDI
- Model / Reference
- GEL-SD EUDAMEDFDA UDI
- Description
- The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor Membrane. GEL-SD is delivered in single dose vials each containing 0.3 g of the solution and is intended for single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17640121880862 EUDAMEDFDA UDI
- Basic UDI-DI
- 764012188GELHF EUDAMED
- FDA Product Code
- LPP FDA UDILKD FDA UDIKLK FDA UDIDQA FDA UDIDPZ FDA UDI
- EMDN Code
- Z1203020405 TRANSCUTANEOUS PO2/PCO2 MONITORS EUDAMED
- GMDN Term
- Pulse Co-oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2500 FDA UDI868.2480 FDA UDI870.2700 FDA UDI870.2710 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Dimensions & Sizes
- Size
- Weight — 0.3 Gram FDA UDI
Contact Gel 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 | 764012188GELHF | 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 20022d8e-6fd4-4c21-83f3-57e53ff5022f 61 fields · synced Jun 1, 2026
- FDA UDI 52e5368e-b856-406a-bc04-a28618b5c2fe 36 fields · synced May 30, 2026