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Denject
EUDAMEDClass IIa (EU MDR)
Ref 30G METRIC XXSHORTModel DenjectRef 30G METRIC XSHORTRef 27G METRIC XXLONGRef 30G METRIC SHORTRef 27G METRIC SHORTRef 27G METRIC LONG
Identity
- Trade Name
- DENJECT EUDAMED
- Model / Reference
- Denject EUDAMED30G METRIC XXSHORT EUDAMED30G METRIC XSHORT EUDAMED27G METRIC XXLONG EUDAMED30G METRIC SHORT EUDAMED27G METRIC SHORT EUDAMED27G METRIC LONG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809312940408 EUDAMED08809312940392 EUDAMED08809312940323 EUDAMED08809312940385 EUDAMED08809312940361 EUDAMED08809312940347 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 (6)
- EUDAMED 3a592140-3242-4c76-8ca2-21977ea9c357 61 fields · synced Aug 4, 2026
- EUDAMED 79fd9eb0-263d-4c12-afbc-ab093df03372 61 fields · synced May 18, 2026
- EUDAMED acff637b-f124-4178-a752-f4caaee28942 61 fields · synced May 18, 2026
- EUDAMED 9b31e9a6-7a4f-4ef7-aabb-bc021b90e6a7 61 fields · synced May 18, 2026
- EUDAMED 417c8996-e406-49ea-9c84-4a83a7aa2238 61 fields · synced May 19, 2026
- EUDAMED 8f1825cb-0058-4d35-b3af-415eed901f94 61 fields · synced May 19, 2026