Identity
- Trade Name
- KONTICUR® Kath G M EUDAMED
- Device Name
- Smili-cath EUDAMED
- Model / Reference
- NCS08M EUDAMEDNCS14M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675356655 EUDAMED
- Basic UDI-DI
- 697067535IMP2ASNNNSNCS1ZH EUDAMEDB-06970675356655 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
KONTICUR® Kath G M by Integral Medical Products Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697067535IMP2ASNNNSNCS1ZH | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697067535IMP2ASNNNSNCS1ZH | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integral Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 96c1f587-0c2b-492d-b28b-5b797c180501 61 fields · synced Jul 9, 2026
- EUDAMED 467817f5-c00a-419b-8ef6-4b64c490b64f 61 fields · synced Jul 9, 2026