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Urinary catheterization/collection kit with Prefilled Syringe
EUDAMEDClass IIa (EU MDR)
Ref ZBY02Model Urinary catheterization/collection kit with Prefilled SyringeRef ZBY01
Identity
- Device Name
- Urinary catheterization/collection kit with Prefilled Syringe EUDAMED
- Model / Reference
- Urinary catheterization/collection kit with Prefilled Syringe EUDAMEDZBY02 EUDAMEDZBY01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977177660396 EUDAMED06977177660372 EUDAMED
- Basic UDI-DI
- 697717766101Q5 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Urinary catheterization/collection kit with Prefilled Syringe by ChangShu Super Medical Equipment Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 697717766101Q5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ChangShu Super Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000040937
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED efc8ddac-30e4-4733-807f-ef24d4f9b2d6 61 fields · synced Oct 6, 2026
- EUDAMED a666e3cb-7c04-4ea9-8e40-f8a74d5fa1e8 61 fields · synced May 18, 2026