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Sterile Urethral Catheters for single use
EUDAMEDClass IIa (EU MDR)
Ref 16FrModel 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr,18Fr,20Fr,22Fr,24Fr,26Fr,28Fr,30Fr
Identity
- Device Name
- Sterile Urethral Catheters for single use EUDAMED
- Model / Reference
- 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr,18Fr,20Fr,22Fr,24Fr,26Fr,28Fr,30Fr EUDAMED16Fr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976523543260 EUDAMED
- Basic UDI-DI
- 697652354DNG001H5 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Sterile Urethral Catheters for single use by Shandong Caremed Medical Products Co., Ltd. — Class IIa — CE/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 | 697652354DNG001H5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Caremed Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000033413
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED f293b9c0-2a98-49d0-9a63-75998223f157 61 fields · synced Oct 8, 2026