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Handle
EUDAMEDClass I (EU MDR)
Ref IS00-35ARef IS08-02Ref IS08-04Ref IS00-10Ref IS08-01Ref IS00-15ARef IS00-10A
Identity
- Trade Name
- Handle EUDAMED
- Device Name
- Orthopaedic Instrument EUDAMED
- Model / Reference
- IS00-35A EUDAMEDIS08-02 EUDAMEDIS08-04 EUDAMEDIS00-10 EUDAMEDIS08-01 EUDAMEDIS00-15A EUDAMEDIS00-10A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045330832 EUDAMED08800045325487 EUDAMED08800045330481 EUDAMED08800045325272 EUDAMED08800045325470 EUDAMED08800045328730 EUDAMED08800045328747 EUDAMED
- Basic UDI-DI
- 88000453BEOTI001KA EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
Handle 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 |
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Manufacturer
- Manufacturer
- ORTHOTECH Co., Ltd
- EUDAMED SRN
- KR-MF-000048890
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (7)
- EUDAMED 535f9657-c965-4f68-b505-f390bab0ef49 61 fields · synced Jul 30, 2026
- EUDAMED 5c66cfc8-1e4b-41a4-bd28-d07315e479d5 61 fields · synced May 17, 2026
- EUDAMED c12408d0-0cf8-4d45-96aa-3822e553d68d 61 fields · synced May 17, 2026
- EUDAMED 4258e26b-c523-4f88-9789-02cfc4eccaec 61 fields · synced May 17, 2026
- EUDAMED 54c56ff7-0317-41c1-9163-d27399de665d 61 fields · synced May 18, 2026
- EUDAMED b4ca733b-7b8a-4fa0-abdd-56628dbc2613 61 fields · synced May 18, 2026
- EUDAMED b4866c74-1fb3-4e01-b22b-d785d2bf1914 61 fields · synced May 18, 2026