Identity
- Trade Name
- Siora EUDAMED
- Device Name
- 2.7mm Locking Head Screw - Self Tapping - (HEX DRIVE 2.0 mm) - Titanium Length 8mm EUDAMED
- Model / Reference
- TI.101.308 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907536085636 EUDAMED
- Basic UDI-DI
- 8907536BSCTI5B EUDAMED
- Direct Marketing DI
- 08907536085636 EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Category: Orthopaedic bone screw (non-sliding)
Siora by Siora Surgicals Pvt. Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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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 | 8907536BSCTI5B | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siora Surgicals Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000036226
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d42f10b6-8d07-425a-ad34-1b2e40866c3e 61 fields · synced Jun 19, 2026