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Patient Application Kit for mature/intact skin
EUDAMEDClass I (EU MDR)
Ref PAK-MI
by Sentec AG
Identity
- Trade Name
- Patient Application Kit for mature/intact skin EUDAMED
- Device Name
- Patient Application Kit EUDAMED
- Model / Reference
- PAK-MI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17640121880961 EUDAMED
- Basic UDI-DI
- 764012188PAKJE EUDAMED
- EMDN Code
- Z1203020405 TRANSCUTANEOUS PO2/PCO2 MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Patient Application Kit for mature/intact skin by SenTec AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764012188PAKJE | Class I | Active |
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Manufacturer
- Manufacturer
- Sentec AG
- EUDAMED SRN
- CH-MF-000008058
- Authorised Representative
- Sentec GmbH DE-AR-000007618
Sources (1)
- EUDAMED 68d0b8eb-75c4-44c1-b779-092069d52bd7 61 fields · synced Jul 11, 2026