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Softfix-Pk

EUDAMED

Class IIb (EU MDR)

Ref 10053Model Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation ScrewRef 10054Ref BAK-7114.30SRef BAK-7166.23Ref BAK-7114.25SRef BAK-7101.20SRef BAK-7170.35Ref BAK-7165.23Ref BAK-7164.20Ref BAK-7168.23Ref BAK-7167.28Ref BAK-7102.20SRef BAK-7168.35Ref BAK-7102.30SRef BAK-7128.25SRef BAK-7167.23Ref BAK-7168.28

by Chetan Meditech Pvt. Ltd.

Identity

Trade Name
SOFTFIX-PK EUDAMED
SOFTFIX EUDAMED
Device Name
BIOTEK, SOFTFIX, SOFTFIX-PK EUDAMED
Model / Reference
Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw EUDAMED
10053 EUDAMED
10054 EUDAMED
BAK-7114.30S EUDAMED
BAK-7166.23 EUDAMED
BAK-7114.25S EUDAMED
BAK-7101.20S EUDAMED
BAK-7170.35 EUDAMED
BAK-7165.23 EUDAMED
BAK-7164.20 EUDAMED
BAK-7168.23 EUDAMED
BAK-7167.28 EUDAMED
BAK-7102.20S EUDAMED
BAK-7168.35 EUDAMED
BAK-7102.30S EUDAMED
BAK-7128.25S EUDAMED
BAK-7167.23 EUDAMED
BAK-7168.28 EUDAMED

Identifiers

Primary DI / UDI-DI
18904210302178 EUDAMED
18904210302185 EUDAMED
18904210300310 EUDAMED
18904210300341 EUDAMED
18904210300303 EUDAMED
18904210300242 EUDAMED
18904210300426 EUDAMED
18904210300334 EUDAMED
18904210301812 EUDAMED
18904210300389 EUDAMED
18904210300372 EUDAMED
18904210300273 EUDAMED
18904210301898 EUDAMED
18904210300297 EUDAMED
18904210300228 EUDAMED
18904210300365 EUDAMED
18904210300396 EUDAMED
Basic UDI-DI
89042103cmplimp006XH EUDAMED
EMDN Code
P09120605 INTERFERENCE SCREWS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Austria EUDAMED
Sweden EUDAMED
Belgium 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

Similar devices

Also classified as Tendon/ligament bone anchor, non-bioabsorbable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 (17)

  • EUDAMED 4c124d74-5fff-4ec8-9581-5499fc2f95a7 61 fields · synced Sep 17, 2026
  • EUDAMED d3d83a5b-52d4-43cb-920a-9d9a9392b5d3 61 fields · synced May 19, 2026
  • EUDAMED 37276c94-212d-4a48-a890-89460841c3af 61 fields · synced Jun 20, 2026
  • EUDAMED f6971069-ce68-4b85-8380-0f251e8e71f3 61 fields · synced Jul 8, 2026
  • EUDAMED cea287d1-f9d3-4a99-8955-fa58a5bee52b 61 fields · synced Jul 9, 2026
  • EUDAMED 56bd1297-65c3-41a5-acad-76968367694d 61 fields · synced Jul 9, 2026
  • EUDAMED 6376a667-ff07-485d-bc95-437c039cec68 61 fields · synced Jul 10, 2026
  • EUDAMED f82dc3c1-c1dd-4283-8350-5273fa520524 61 fields · synced Jul 10, 2026
  • EUDAMED a256a14c-2e77-4e7a-a765-ddc6aa070099 61 fields · synced Jul 13, 2026
  • EUDAMED 90b94f1b-0350-438c-b475-608be42af662 61 fields · synced Jul 17, 2026
  • EUDAMED 52de9a80-dcde-4548-9631-874e2fb4388c 61 fields · synced Jul 20, 2026
  • EUDAMED 7df887ca-3b8c-4e49-be4d-0af219d233a9 61 fields · synced Jul 25, 2026
  • EUDAMED 72ae0aec-4e54-4c20-8d77-78d153e4a494 61 fields · synced Jul 29, 2026
  • EUDAMED 701b1998-e9c0-439f-8ef3-d6b351369a11 61 fields · synced Jul 31, 2026
  • EUDAMED e53745b5-9ce1-4fc2-aa00-956db38d27b1 61 fields · synced Jul 31, 2026
  • EUDAMED eb6a17f1-d139-4a4b-98f3-c8c306df3c80 61 fields · synced Aug 3, 2026
  • EUDAMED a5645ab2-4c71-4864-96f3-3019a0cafb22 61 fields · synced Sep 17, 2026