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Softfix-Pk
EUDAMEDClass IIb (EU MDR)
Ref BAK-7164.15Model Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw
Identity
- Trade Name
- SOFTFIX-PK EUDAMED
- Device Name
- BIOTEK, SOFTFIX, SOFTFIX-PK EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw EUDAMEDBAK-7164.15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210301805 EUDAMED
- Basic UDI-DI
- 89042103cmplimp006XH EUDAMED
- EMDN Code
- P09120605 INTERFERENCE SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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: Tendon/ligament bone anchor, non-bioabsorbable
Softfix-Pk by Chetan Meditech Pvt. Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
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 | 89042103cmplimp006XH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Chetan Meditech Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000013541
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e3b6e46f-6eeb-42d9-a51c-eeaa075ef20d 61 fields · synced Jun 19, 2026