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Urethral Catheters for single use
EUDAMEDClass IIb (EU MDR)
Ref Silicone-two way-10Fr
Identity
- Trade Name
- Urethral Catheters for single use EUDAMED
- Device Name
- Urethral Catheters for single use EUDAMED
- Model / Reference
- Silicone-two way-10Fr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941730281380 EUDAMED
- Basic UDI-DI
- B-06941730281380 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON 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
Urethral Catheters for single use by Nanchang Kanghua Health Materials Co., Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941730281380 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nanchang Kanghua Health Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000014308
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 73b35693-9a19-4740-8e6c-552f0aff349e 61 fields · synced Jul 16, 2026