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Redmond Cervical Implants
EUDAMEDClass IIb (EU MDR)
Ref 1051-55548HModel Redmond Cervical ImplantsRef 1051-57548HRef 1051-57528HRef 1053-168Ref 1051-55528HRef 1051-58548HRef 1057-148Ref 1051-56548H
Identity
- Trade Name
- Redmond Cervical Implants EUDAMED
- Device Name
- Redmond Cervical Implant EUDAMEDVariable Screw (Self Drilling) EUDAMEDVariable Screw (Oversized) EUDAMED
- Model / Reference
- Redmond Cervical Implants EUDAMED1051-55548H EUDAMED1051-57548H EUDAMED1051-57528H EUDAMED1053-168 EUDAMED1051-55528H EUDAMED1051-58548H EUDAMED1057-148 EUDAMED1051-56548H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710704026423 EUDAMED04710704026447 EUDAMED04711021936075 EUDAMED04711021934651 EUDAMED04711021936051 EUDAMED04710704026454 EUDAMED04711021934101 EUDAMED04710704026430 EUDAMED
- Basic UDI-DI
- B-04710704026423 EUDAMEDB-04710704026447 EUDAMEDB-04711021936075 EUDAMEDB-04711021934651 EUDAMEDB-04711021936051 EUDAMEDB-04710704026454 EUDAMEDB-04711021934101 EUDAMEDB-04710704026430 EUDAMED
- EMDN Code
- P09070101 SPINAL CAGES EUDAMEDP09070199 SPINAL FUSION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Redmond Cervical Implants by A-SPINE Asia 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-04710704026423 | Class IIb | 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 (8)
- EUDAMED f5468694-8734-40db-9eaf-8d60203393ff 61 fields · synced Sep 30, 2026
- EUDAMED 439d7a21-1d36-4580-a6ee-d1951bc60258 61 fields · synced May 18, 2026
- EUDAMED d08ea580-e7e7-4bf3-9cc0-642287f31300 61 fields · synced May 18, 2026
- EUDAMED d3410e4d-039e-44f9-86fa-0521a25302a8 61 fields · synced May 18, 2026
- EUDAMED 4b21c409-9970-4d42-a74a-1960528f90ae 61 fields · synced May 18, 2026
- EUDAMED edbb0f2b-705f-4f90-bc85-d27ccd1279a4 61 fields · synced May 18, 2026
- EUDAMED 9ca85a77-c41e-4e2b-97b5-7362065ad828 61 fields · synced May 18, 2026
- EUDAMED 00fe75ac-edc6-4725-9cef-c21fced4636a 61 fields · synced May 19, 2026