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Bone screw - Bone screw

EUDAMED

Class IIb (EU MDR)

Ref 397129796210Model ScrewRef 397129796210S

by MEDIN, a.s.

Identity

Trade Name
Bone screw; cancellous, HB 4×12/5 mm EUDAMED
Bone screw sterile; cancellous, HB 4×12/5 mm EUDAMED
Device Name
Bone screw EUDAMED
Bone screw sterile EUDAMED
Model / Reference
Screw EUDAMED
397129796210 EUDAMED
397129796210S EUDAMED

Identifiers

Primary DI / UDI-DI
08591712389092 EUDAMED
08591712390944 EUDAMED
Basic UDI-DI
85917126030101VS EUDAMED
85917126030101SP9 EUDAMED
Direct Marketing DI
08591712389092 EUDAMED
08591712390944 EUDAMED
EMDN Code
P09120602 CANCELLOUS SCREWS EUDAMED
Models / Variants
Bone screw EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Czechia EUDAMED

Clinical & Handling

Sterile

No

EUDAMEDEUDAMED

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

Bone screw - Bone screw by MEDIN, a.s. — Class IIb — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
MEDIN, a.s.
EUDAMED SRN
CZ-MF-000012371

Sources (2)

  • EUDAMED 8510409f-93b3-4e49-80f4-63237c8284ea 61 fields · synced Jul 23, 2026
  • EUDAMED a0fd73c0-e890-435d-b749-9268b44ee1be 61 fields · synced May 18, 2026