Identity
- Trade Name
- FORLNK™ Manual Retraction Kit EUDAMED
- Device Name
- FORLNK™ Manual Retraction Kit EUDAMED
- Model / Reference
- EPAS 125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952450973950 EUDAMED
- Basic UDI-DI
- 69524509C6A10FF EUDAMED
- EMDN Code
- C020399 CARDIAC TISSUE ABLATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
FORLNK™ Manual Retraction Kit by Shanghai Microport Ep Medtech 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69524509C6A10FF | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort EP MedTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008518
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 05873513-2e29-4891-8af5-d53fe2adc1e7 61 fields · synced Jun 18, 2026