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Sorath Ortho, Sorath
EUDAMEDClass IIb (EU MDR)
Ref A16701008Model Cortical Bone Screw, Dia. 2.7 mm, Torx, 08 mm, SS316L
Identity
- Trade Name
- Sorath Ortho, Sorath EUDAMED
- Device Name
- Cortical Bone Screw, Dia. 2.7 mm, Torx, 08 mm, SS316L EUDAMED
- Model / Reference
- Cortical Bone Screw, Dia. 2.7 mm, Torx, 08 mm, SS316L EUDAMEDA16701008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G500A167010080 EUDAMED
- Basic UDI-DI
- B-G500A167010080 EUDAMED
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Sorath Ortho, Sorath by Sigma Surgical Private Limited — 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-G500A167010080 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sigma Surgical Private Limited
- EUDAMED SRN
- IN-MF-000013665
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 84da0033-44bf-4845-84fc-ed2a8243bc31 61 fields · synced Jun 18, 2026