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Rthrox
EUDAMEDClass IIb (EU MDR)
Ref BA114.35Model Acl Interference Screw (Round Thread)
Identity
- Trade Name
- RTHROX EUDAMED
- Device Name
- ARTHROSCOPY IMPLANTS EUDAMED
- Model / Reference
- Acl Interference Screw (Round Thread) EUDAMEDBA114.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G562BA114350 EUDAMED
- Basic UDI-DI
- ++G562ARBM EUDAMED
- Direct Marketing DI
- G562BA114350 EUDAMED
- EMDN Code
- K030299 ARTHROSCOPY SURGICAL INSTRUMENTS, SINGLE USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Rthrox by Bonetech Medisys Pvt. Ltd. — Class IIb — 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 | ++G562ARBM | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bonetech Medisys Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000020462
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 16d42773-6a08-42bc-b962-12cd0fc23ca8 61 fields · synced Jun 18, 2026