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Patient Application Kit for sensitive/fragile skin
EUDAMEDFDA UDIClass I (EU MDR)
Ref PAK-SF
by Sentec AG
Identity
- Trade Name
- Patient Application Kit for sensitive/fragile skin EUDAMEDFDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- Patient Application Kit EUDAMEDA combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin. FDA UDI
- Model / Reference
- PAK-SF EUDAMEDFDA UDI
- Description
- A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880971 EUDAMEDFDA UDI
- Basic UDI-DI
- 764012188PAKJE EUDAMED
- FDA Product Code
- DPZ FDA UDIDQA FDA UDIKLK FDA UDILKD FDA UDILPP FDA UDI
- EMDN Code
- Z1203020405 TRANSCUTANEOUS PO2/PCO2 MONITORS EUDAMED
- GMDN Term
- Transcutaneous blood gas monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2710 FDA UDI870.2700 FDA UDI868.2500 FDA UDI868.2480 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Yes
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
Patient Application Kit for sensitive/fragile skin 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 | 764012188PAKJE | 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 450f496c-aafe-4599-9c39-b48ea03ce3c9 61 fields · synced Jun 18, 2026
- FDA UDI 27e26713-f709-46ff-8be0-92e46bc71524 36 fields · synced May 30, 2026