Identity
- Trade Name
- BIODEL EUDAMED
- Device Name
- BIODEGRADABLE NITRILE POWDER FREE EXAMINATION GLOVES EUDAMED
- Model / Reference
- BIODEL EUDAMEDPPMD04EU EUDAMEDPPMD02EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860011343806 EUDAMED00860011343851 EUDAMED
- Basic UDI-DI
- 08600113438BIODELNGCQ EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Biodel by Medzah Industries — 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 | 08600113438BIODELNGCQ | Class I | Active |
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Manufacturer
- Manufacturer
- Medzah Industries
- EUDAMED SRN
- US-MF-000039359
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (2)
- EUDAMED 978b852f-93e1-43ee-9e07-0a31049025c9 61 fields · synced Jul 9, 2026
- EUDAMED f39723a7-fdb6-4f68-a8d8-08b1646d2b0d 61 fields · synced May 18, 2026