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Variable Screw (Self Tapping)
EUDAMEDClass III (EU MDR)
Ref 1054-168Ref 1054-128Ref 1054-158Ref 1054-148Ref 1054-208
Identity
- Trade Name
- Variable Screw (Self Tapping) EUDAMED
- Device Name
- Redmond Cervical Implants EUDAMED
- Model / Reference
- 1054-168 EUDAMED1054-128 EUDAMED1054-158 EUDAMED1054-148 EUDAMED1054-208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711021936419 EUDAMED04711021936372 EUDAMED04711021936402 EUDAMED04711021936396 EUDAMED04711021936440 EUDAMED
- Basic UDI-DI
- B-04711021936419 EUDAMEDB-04711021936372 EUDAMEDB-04711021936402 EUDAMEDB-04711021936396 EUDAMEDB-04711021936440 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 Tapping) 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-04711021936419 | 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 (5)
- EUDAMED 4ce484eb-726f-4a03-b3cf-fed8710ec69f 61 fields · synced Sep 18, 2026
- EUDAMED aa2aa6cc-96bb-48c4-a636-ed3fc0a696b3 61 fields · synced May 17, 2026
- EUDAMED e0e7d4ea-030a-4781-9275-9c74db58a08a 61 fields · synced May 18, 2026
- EUDAMED cd5efaf6-a4ca-481f-a6a6-a4545bb32a49 61 fields · synced May 19, 2026
- EUDAMED bbbeb0ab-3bde-4a28-8e82-4ca60069688c 61 fields · synced May 19, 2026