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BioHorizons
EUDAMEDClass I (EU MDR)
Ref PROID30Model BioHorizons Conical Dental Instruments
Identity
- Trade Name
- BioHorizons EUDAMED
- Device Name
- Depth Indicators EUDAMED
- Model / Reference
- BioHorizons Conical Dental Instruments EUDAMEDPROID30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847236028053 EUDAMED
- Basic UDI-DI
- 08472360IRINST013EZ EUDAMED
- Direct Marketing DI
- 00847236027698 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
BioHorizons by Biohorizons Implant Systems Inc. — 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 | 08472360IRINST013EZ | Class I | Active |
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Manufacturer
- Manufacturer
- BioHorizons Implant Systems Inc.
- EUDAMED SRN
- US-MF-000014002
- Authorised Representative
- ALTATEC GmbH DE-AR-000006232
Sources (1)
- EUDAMED 14144778-b428-4658-a2ca-de628c68c2dd 61 fields · synced Aug 3, 2026