← Back to catalogue
bio-UMAXX 100% SILIKON FOLEY KATHETER
EUDAMEDClass IIb (EU MDR)
Ref FC18210DModel FC06201DP
Identity
- Trade Name
- bio-UMAXX 100% SILIKON FOLEY KATHETER EUDAMED
- Device Name
- Silicone Foley Catheter EUDAMED
- Model / Reference
- FC06201DP EUDAMEDFC18210D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675357256 EUDAMED
- Basic UDI-DI
- 697067535IMP2BSNNNSFC00VE EUDAMEDB-06970675357256 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
bio-UMAXX 100% SILIKON FOLEY KATHETER by Integral Medical Products Co., Ltd. — Class IIb — 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 | 697067535IMP2BSNNNSFC00VE | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697067535IMP2BSNNNSFC00VE | Class IIb | 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 7cbf64eb-7b41-4104-9a63-3a8b47b85b2a 61 fields · synced Oct 6, 2026
- EUDAMED 953801a5-4e61-4dbf-a494-12710743e5bb 61 fields · synced Jul 19, 2026