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Gima
EUDAMEDClass I (EU MDR)
Ref LDEModel LDA; LDC; LDE; LDF; LDC-Ⅱ; LDE-Ⅱ; LDF-Ⅱ
Identity
- Trade Name
- GIMA EUDAMED
- Device Name
- Lacing Devices EUDAMED
- Model / Reference
- LDA; LDC; LDE; LDF; LDC-Ⅱ; LDE-Ⅱ; LDF-Ⅱ EUDAMEDLDE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949517008083 EUDAMED
- Basic UDI-DI
- 694951701VA EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Device sterilization/disinfection container, reusable
Gima by Shandong Lianfa Medical Plastic Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 694951701VA | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Lianfa Medical Plastic Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000028790
- Authorised Representative
- Linkfar Healthcare GmbH DE-AR-000005107
Sources (1)
- EUDAMED 2558b1f3-2179-4981-85a1-35ac590cc84c 61 fields · synced Oct 7, 2026