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Dental Needle 27G INCH XLONG
EUDAMEDClass IIa (EU MDR)
Ref Dental Needle 27G INCH XLONGModel DENJECT
Identity
- Trade Name
- Dental Needle 27G INCH XLONG EUDAMED
- Model / Reference
- DENJECT EUDAMEDDental Needle 27G INCH XLONG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809312940422 EUDAMED
- Basic UDI-DI
- 880931294needleMX EUDAMED
- Direct Marketing DI
- 08809312940422 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
Dental Needle 27G INCH XLONG 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 | 880931294needleMX | 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 57b24688-be72-4217-a8b1-359df11fbb26 61 fields · synced Aug 1, 2026