Identity
- Trade Name
- UltraDrain Suprapubic Puncture Set EUDAMED
- Device Name
- SUPRAPUBIC DRAINAGE SET EUDAMED
- Model / Reference
- SPS12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812261012537 EUDAMED
- Basic UDI-DI
- 081226101SDS008SZ EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
UltraDrain Suprapubic Puncture Set by Allwin Medical Devices, Inc. — Class IIa — 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 | 081226101SDS008SZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc
- EUDAMED SRN
- US-MF-000011349
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a997da00-c414-49f9-9487-7991400b0824 61 fields · synced Jul 21, 2026