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Bone Management
EUDAMEDFDA UDIClass I (EU MDR)
Ref CL013Model Accessories implantology and oral surgery
Identity
- Trade Name
- Bone Management EUDAMEDn/a FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Manual instrument for dental/surgical application FDA UDI
- Model / Reference
- Accessories implantology and oral surgery EUDAMEDCL013 EUDAMEDFDA UDI
- Description
- Manual instrument for dental/surgical application FDA UDI
Identifiers
- Catalog Number
- CL013 FDA UDI
- Primary DI / UDI-DI
- E0HM36CL0131 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E0HM351I01ACPH EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bone Management by Hager & Meisinger GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E0HM351I01ACPH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hager & Meisinger GmbH
- EUDAMED SRN
- DE-MF-000004966
Sources (2)
- EUDAMED a74c1814-4376-490a-adfb-93cbcacec6ac 61 fields · synced Jun 9, 2026
- FDA UDI 224cc851-07a5-42a9-a6d8-8d0796399ddc 35 fields · synced May 30, 2026