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Disposable Endoscopic Trocar
EUDAMEDClass IIa (EU MDR)
Ref FH07Model FT SeriesModel FP Series,BP SeriesModel BT SeriesModel BT Series, AR Series
Identity
- Trade Name
- Disposable Endoscopic Trocar EUDAMED
- Device Name
- Disposable Endoscopic Trocar EUDAMED
- Model / Reference
- FT Series EUDAMEDFH07 EUDAMEDFP Series,BP Series EUDAMEDBT Series EUDAMEDBT Series, AR Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348303957 EUDAMED06921348303964 EUDAMED06921348304312 EUDAMED06921348332636 EUDAMED06921348304398 EUDAMED
- Basic UDI-DI
- 69213483FH0703R6W EUDAMED69213483FH0702R6T EUDAMED69213483FH0701R6Q EUDAMED69213483FH0701E5W EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Disposable Endoscopic Trocar by Fengh Medical Co., Ltd. — Class IIa — 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 | 69213483FH0703R6W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fengh Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000004718
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (5)
- EUDAMED d4f57dac-e293-4c7f-b173-34d5bac550a6 61 fields · synced Sep 30, 2026
- EUDAMED 7da7b3e3-eeed-463c-bae2-94ed0112bf11 61 fields · synced May 17, 2026
- EUDAMED 05304879-2b8c-4b0c-8c32-e6b2c5caca87 61 fields · synced May 18, 2026
- EUDAMED 193c611f-a188-41d4-b1c7-47cbbc63bc4f 61 fields · synced Sep 17, 2026
- EUDAMED 2134ec47-a4d1-4d7d-b9c1-1958e96f3a51 61 fields · synced Sep 30, 2026