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Variable Screw (Oversized)
EUDAMEDClass III (EU MDR)
Ref 1057-208Ref 1057-188Ref 1057-138Ref 1057-178
Identity
- Trade Name
- Variable Screw (Oversized) EUDAMED
- Device Name
- Redmond Cervical Implants EUDAMED
- Model / Reference
- 1057-208 EUDAMED1057-188 EUDAMED1057-138 EUDAMED1057-178 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711021936495 EUDAMED04711021936488 EUDAMED04711021936457 EUDAMED04711021936471 EUDAMED
- Basic UDI-DI
- B-04711021936495 EUDAMEDB-04711021936488 EUDAMEDB-04711021936457 EUDAMEDB-04711021936471 EUDAMED
- EMDN Code
- P09070199 SPINAL FUSION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Variable Screw (Oversized) by A-SPINE Asia Co., Ltd. — Class III — 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-04711021936495 | Class III | Active |
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Manufacturer
- Manufacturer
- A-SPINE Asia Co., Ltd.
- EUDAMED SRN
- TW-MF-000017454
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (4)
- EUDAMED a2e57857-b018-4113-9e9b-a44dc42b2569 61 fields · synced Oct 6, 2026
- EUDAMED 122f7467-8eab-4c72-8ddb-9808cdcf9836 61 fields · synced May 18, 2026
- EUDAMED efa3af22-f766-40bf-9343-c3db5c4e7028 61 fields · synced May 19, 2026
- EUDAMED 842449d4-b0bd-425d-aef1-5d1f1aae2bac 61 fields · synced May 19, 2026