Identity
- Device Name
- Suprapubic Catheter Sets EUDAMED
- Model / Reference
- 1034P-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809690072791 EUDAMED
- Basic UDI-DI
- B-08809690072791 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
Suprapubic Catheter Sets by Yushin Medical 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-08809690072791 | 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 e672439c-fc89-4c51-b1cf-7e0725f47ecf 61 fields · synced Jun 18, 2026