Identity
- Trade Name
- Orthopaedic Cement Mixer EUDAMED
- Device Name
- Orthopaedic Instrument EUDAMED
- Model / Reference
- C-A103 EUDAMEDC-A102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045330917 EUDAMED08800045325890 EUDAMED
- Basic UDI-DI
- 88000453BEOTI001KA EUDAMED
- EMDN Code
- P099001 ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Orthopaedic Cement Mixer by ORTHOTECH Co., Ltd — 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 | 88000453BEOTI001KA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ORTHOTECH Co., Ltd
- EUDAMED SRN
- KR-MF-000048890
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED d1de77cd-b662-4c51-86cb-78053dd28879 61 fields · synced Jul 23, 2026
- EUDAMED 41bb8bf3-e332-433f-be5b-9d0e142c108c 61 fields · synced May 19, 2026