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Orthopaedic Surgical Instrument - Container
EUDAMEDClass I (EU MDR)
Ref 91-8839
Identity
- Device Name
- Orthopaedic Surgical Instrument - Container EUDAMED
- Model / Reference
- 91-8839 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B7689188390P EUDAMED
- Basic UDI-DI
- ++B768TF5TM EUDAMED
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Orthopaedic Surgical Instrument - Container by Buxton Biomedical, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B768TF5TM | Class I | Active |
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Manufacturer
- Manufacturer
- Buxton BioMedical, inc.
- EUDAMED SRN
- US-MF-000035059
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED fce25974-f0dc-402c-bd22-450b6324ee7e 61 fields · synced Jun 19, 2026