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Isolation Transformer
EUDAMEDFDA UDIClass I (EU MDR)
Ref RFT100VA-V1
by Sentec AG
Identity
- Trade Name
- Isolation Transformer EUDAMEDIsolation Transformer 100-120V FDA UDI
- Generic Name
- Pulse Co-oximeter probe, reusable FDA UDI
- Device Name
- Isolation Transformer EUDAMEDIsolates the SDM from mains for use in home use environments. FDA UDI
- Model / Reference
- RFT100VA-V1 EUDAMEDFDA UDI
- Description
- Isolates the SDM from mains for use in home use environments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880902 EUDAMEDFDA UDI
- Basic UDI-DI
- 764012188RFTKR EUDAMED
- Direct Marketing DI
- 07640121880902 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Isolation Transformer 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 | 764012188RFTKR | 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 46d37dbd-0193-4efe-a7a5-7914a1b20408 61 fields · synced Jun 19, 2026
- FDA UDI c57cd078-dadf-4d87-bd19-834fb053b691 35 fields · synced May 30, 2026