Identity
- Trade Name
- Fourie Safety System With Agitator EUDAMED
- Device Name
- Fourie Safety System With Agitator EUDAMED
- Model / Reference
- URO 039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009900408354 EUDAMED
- Basic UDI-DI
- 60099004083URO0393K EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Fourie Safety System With Agitator by Wismed (PTY) Ltd — Class I — 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 | 60099004083URO0393K | Class I | Active |
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Manufacturer
- Manufacturer
- Wismed (PTY) Ltd
- EUDAMED SRN
- ZA-MF-000035555
- Authorised Representative
- TNMC Devices Llc HR-AR-000019582
Sources (1)
- EUDAMED 4db55e9f-cfc6-4204-b6a7-28bdb61ba23f 61 fields · synced Jul 16, 2026