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Bone screw sterile +1 more model

EUDAMED

Class IIb (EU MDR)

Ref 397129796401SModel ScrewRef 397129796701S

by MEDIN, a.s.

Identity

Trade Name
Bone screw sterile; cancellous, self-tapping, HB 6.5×25 mm EUDAMED
Bone screw sterile; cancellous, self-tapping, HB 6.5×25/16 mm EUDAMED
Device Name
Bone screw sterile EUDAMED
Model / Reference
Screw EUDAMED
397129796401S EUDAMED
397129796701S EUDAMED

Identifiers

Primary DI / UDI-DI
08591712391163 EUDAMED
08591712391224 EUDAMED
Basic UDI-DI
85917126030101SP9 EUDAMED
Direct Marketing DI
08591712391163 EUDAMED
08591712391224 EUDAMED
EMDN Code
P09120602 CANCELLOUS SCREWS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Czechia 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

Bone screw sterile +1 more model 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 79a48ecf-d664-4b34-86a5-93facc5f242a 61 fields · synced Jul 24, 2026
  • EUDAMED d47f8613-effe-4791-ae9f-cb6fb502928c 61 fields · synced May 18, 2026