Identity
- Trade Name
- Disposable Bone Access Tool EUDAMED
- Device Name
- Disposable Spinal Fixation Instrument Set EUDAMED
- Model / Reference
- SR-TB35-0100-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949980794490 EUDAMED
- Basic UDI-DI
- B-06949980794490 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Category: Joint prosthesis implantation kit, single-use
Disposable Bone Access Tool by Shanghai REACH Medical Instrument Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06949980794490 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai REACH Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000010269
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e7091ac1-d8ed-4fcc-b7a7-651b124d1674 61 fields · synced Jul 22, 2026