Identity
- Trade Name
- General Semi Bowl 1500ml EUDAMED
- Device Name
- Moulded Pulps EUDAMED
- Model / Reference
- GSB1500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 95510204300762 EUDAMED
- Basic UDI-DI
- 955102043PULPEV EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
General Semi Bowl 1500ml by Apex Pulp Sdn.bhd — 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 | 955102043PULPEV | Class I | Active |
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Manufacturer
- Manufacturer
- Apex Pulp Sdn.bhd
- EUDAMED SRN
- MY-MF-000037312
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ff13f0d8-5835-435f-90c5-b8b46fe9b97a 61 fields · synced Jul 17, 2026