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Disposable Endoscopic Linear Cutter Reloads
EUDAMEDClass IIb (EU MDR)
Ref FH19Model FM Series, FA Series, DM Series, DA SeriesModel FA Series, FR Series, DA Series, DR Series,Model FA Series, DA Series, FR Series, DR Series
Identity
- Trade Name
- Disposable Endoscopic Linear Cutter Reloads EUDAMED
- Device Name
- Disposable Endoscopic Linear Cutter Reloads EUDAMED
- Model / Reference
- FM Series, FA Series, DM Series, DA Series EUDAMEDFH19 EUDAMEDFA Series, FR Series, DA Series, DR Series, EUDAMEDFA Series, DA Series, FR Series, DR Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348308983 EUDAMED06921348306750 EUDAMED06921348307030 EUDAMED06921348309188 EUDAMED
- Basic UDI-DI
- 69213483FH1902E6S EUDAMED69213483FH1901E6P EUDAMED69213483FH1901R7H EUDAMED69213483FH1902R7L EUDAMED
- EMDN Code
- H02030106 LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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
Disposable Endoscopic Linear Cutter Reloads by Fengh Medical Co., Ltd. — Class IIb — 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 | 69213483FH1902E6S | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fengh Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000004718
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (4)
- EUDAMED c51c3a0d-b823-457e-b246-088fa9d2096e 61 fields · synced Sep 18, 2026
- EUDAMED b9a63c67-6351-429e-9252-d4d91d585c59 61 fields · synced May 19, 2026
- EUDAMED ac3ac0b1-c62a-400f-814a-cd61a14f3a17 61 fields · synced May 19, 2026
- EUDAMED 2eed494b-f55d-461a-871e-34123f181447 61 fields · synced May 19, 2026