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“A-Spine” Orthopedic Manual Surgical Instruments (Non-Sterile)
EUDAMEDClass I (EU MDR)
Ref 229-1703Model “A-Spine” Orthopedic Manual Surgical Instruments (Non-Sterile)
Identity
- Trade Name
- “A-Spine” Orthopedic Manual Surgical Instruments (Non-Sterile) EUDAMED
- Device Name
- Universal Insertor EUDAMED
- Model / Reference
- “A-Spine” Orthopedic Manual Surgical Instruments (Non-Sterile) EUDAMED229-1703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711021934040 EUDAMED
- Basic UDI-DI
- B-04711021934040 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
“A-Spine” Orthopedic Manual Surgical Instruments (Non-Sterile) by A-SPINE Asia Co., Ltd. — Class I — 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-04711021934040 | Class I | 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 (1)
- EUDAMED 048ac3b1-0a92-45ea-b08b-338c0bac7708 61 fields · synced Jun 18, 2026