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Anatomic Midshaft Forearm Plate, A-type
EUDAMEDClass IIb (EU MDR)
Ref 1025-12004
Identity
- Device Name
- Anatomic Midshaft Forearm Plate, A-type EUDAMED
- Model / Reference
- 1025-12004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809407606219 EUDAMED
- Basic UDI-DI
- B-08809407606219 EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Anatomic Midshaft Forearm Plate, A-type by Hankil Tech Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809407606219 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hankil tech medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000008326
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 16dab618-92b2-44c6-bbff-95c8988ac8a5 61 fields · synced Jul 21, 2026