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Disposable Endoscopic Trocar
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FH07Model BT Series
Identity
- Trade Name
- Disposable Endoscopic Trocar EUDAMED
- Device Name
- Disposable Endoscopic Trocar EUDAMED
- Model / Reference
- BT Series EUDAMEDFH07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348304336 EUDAMED
- Basic UDI-DI
- 69213483FH0701E5W 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180208 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69213483FH0701E5W | 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 (2)
- EUDAMED 36e04663-b89b-4cc7-93a6-0d878903e668 61 fields · synced Jun 19, 2026
- FDA 510(k) K180208 1 fields · synced May 18, 2026