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Variable Screw (Self Drilling)
EUDAMEDClass III (EU MDR)
Ref 1053-208Ref 1053-158
Identity
- Trade Name
- Variable Screw (Self Drilling) EUDAMED
- Device Name
- Redmond Cervical Implants EUDAMED
- Model / Reference
- 1053-208 EUDAMED1053-158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711021936365 EUDAMED04711021936334 EUDAMED
- Basic UDI-DI
- B-04711021936365 EUDAMEDB-04711021936334 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 (Self Drilling) 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-04711021936365 | 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 (2)
- EUDAMED b38ef001-132d-4559-a299-48166b7a7a2b 61 fields · synced Jul 31, 2026
- EUDAMED 78269e32-aa56-4adc-b6fc-5d0d62ce5426 61 fields · synced May 17, 2026