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Disposable Endoscopic Trocar Sleeves
EUDAMEDClass IIa (EU MDR)
Ref FH07SModel BT Series
Identity
- Trade Name
- Disposable Endoscopic Trocar Sleeves EUDAMED
- Device Name
- Disposable Endoscopic Trocar Sleeves EUDAMED
- Model / Reference
- BT Series EUDAMEDFH07S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348305036 EUDAMED
- Basic UDI-DI
- 69213483FH07S01RE2 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 Sleeves 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 | 69213483FH07S01RE2 | 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 (1)
- EUDAMED 568ccea4-6bed-4e1c-a680-a5dea80c62e5 61 fields · synced Jun 18, 2026