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Guide Pin

EUDAMED

Class I (EU MDR)

Ref IG32-10Ref IG42-18Ref IS15-07Ref IS16-07Ref C0012

by ORTHOTECH Co., Ltd

Identity

Trade Name
Guide Pin EUDAMED
Device Name
Orthopaedic Instrument EUDAMED
Model / Reference
IG32-10 EUDAMED
IG42-18 EUDAMED
IS15-07 EUDAMED
IS16-07 EUDAMED
C0012 EUDAMED

Identifiers

Primary DI / UDI-DI
08800045328778 EUDAMED
08800045327337 EUDAMED
08800045325647 EUDAMED
08800045325715 EUDAMED
08800045323452 EUDAMED
Basic UDI-DI
88000453BEOTI001KA EUDAMED
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

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

Guide Pin by ORTHOTECH Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
ORTHOTECH Co., Ltd
EUDAMED SRN
KR-MF-000048890
Authorised Representative
AF Pharma Service Europe SL ES-AR-000018076

Sources (5)

  • EUDAMED 460e67bb-8126-4e32-9cfc-37134723e3ba 61 fields · synced Jul 24, 2026
  • EUDAMED 8315cd3a-3796-49c5-af00-5fbb514d8503 61 fields · synced May 16, 2026
  • EUDAMED 84875145-cb5d-4ad1-a677-9d7e4fa34274 61 fields · synced May 16, 2026
  • EUDAMED 06ca19be-55ae-469b-a913-d01c61973cde 61 fields · synced May 17, 2026
  • EUDAMED 4256d8d1-5827-4a60-9970-d4de53d28401 61 fields · synced May 17, 2026