Identity
- Trade Name
- DENJECT EUDAMED
- Model / Reference
- Denject EUDAMED30G METRIC LONG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809312940378 EUDAMED
- Basic UDI-DI
- 880931294DBUDIGK EUDAMED
- EMDN Code
- A010601 CARPULE NEEDLES EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Denject by Biodent Co., Ltd — 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 | 880931294DBUDIGK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biodent Co., Ltd
- EUDAMED SRN
- KR-MF-000043709
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 32ef92f9-11a0-448e-a022-5d65b6199e69 61 fields · synced Jun 19, 2026