Identity
- Device Name
- Suprapubic Catheter Sets EUDAMED
- Model / Reference
- 1034P-14-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809690082738 EUDAMED
- Basic UDI-DI
- B-08809690082738 EUDAMED
- EMDN Code
- U040102 KITS WITH DRAINAGE CATHETERS AND INTRODUCERS 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
Category: Suprapubic drainage catheter
Suprapubic Catheter Sets by Yushin Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08809690082738 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Yushin Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000010526
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED d28c869b-a84d-4b1a-af9a-1c10532b24f8 61 fields · synced Jun 18, 2026