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Broken Help Kit Guide Handle
EUDAMEDClass I (EU MDR)
Ref S-BHKGHDL
by Novodent SA
Identity
- Trade Name
- Broken Help Kit Guide Handle EUDAMED
- Device Name
- Dental Implant System Components EUDAMED
- Model / Reference
- S-BHKGHDL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188214536 EUDAMED
- Basic UDI-DI
- 763018820003BX EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Broken Help Kit Guide Handle by Novodent SA — 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 | 763018820003BX | Class I | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4f11c5bb-0cc1-4632-b2c7-5e9400faeb35 61 fields · synced Jul 9, 2026