Identity
- Trade Name
- UROMETER 500 ML EUDAMED
- Device Name
- Measured Volume Chamber with Urine Collection Bag EUDAMED
- Model / Reference
- GS-1018-500E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120101846 EUDAMED
- Basic UDI-DI
- 8902120A009RQ EUDAMED
- EMDN Code
- A06030302 HOURLY DIURESIS MEASUREMENT SETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Urometer 500 Ml by Romsons International (Unit II) — 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 | 8902120A009RQ | Class I | Active |
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Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 86b9ccea-1d60-4554-9a72-8237c97c3acf 61 fields · synced Jun 18, 2026