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Disposable Endoscopic Trocar Sleeves
EUDAMEDClass IIa (EU MDR)
Ref FH07SModel FT SeriesModel BT SeriesModel FP Series, BP SeriesModel B5ST,B5LT,B5XT, B8ST,B8LT,B8XT, B10ST,B10LT,B10XT, B11ST,B11LT,B11XT, B12ST,B12LT,B12XT, B15ST,B15LT,B15XT, F5SP,F5LP,F5XP, F8SP,F8LP,F8XP, F10SP,F10LP,F10XP, F11SP,F11LP,F11XP, F12SP,F12LP,F12XP, F15SP,F15LP,F15XP
Identity
- Trade Name
- Disposable Endoscopic Trocar Sleeves EUDAMED
- Device Name
- Disposable Endoscopic Trocar Sleeves EUDAMED
- Model / Reference
- FT Series EUDAMEDFH07S EUDAMEDBT Series EUDAMEDFP Series, BP Series EUDAMEDB5ST,B5LT,B5XT, B8ST,B8LT,B8XT, B10ST,B10LT,B10XT, B11ST,B11LT,B11XT, B12ST,B12LT,B12XT, B15ST,B15LT,B15XT, F5SP,F5LP,F5XP, F8SP,F8LP,F8XP, F10SP,F10LP,F10XP, F11SP,F11LP,F11XP, F12SP,F12LP,F12XP, F15SP,F15LP,F15XP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348304671 EUDAMED06921348305098 EUDAMED06921348304688 EUDAMED06921348305043 EUDAMED06921348305296 EUDAMED
- Basic UDI-DI
- 69213483FH07S03RE8 EUDAMED69213483FH07S01ED8 EUDAMED69213483FH07S02RE5 EUDAMED69213483FH07S02EDB 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 | 69213483FH07S03RE8 | 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 28cc21ba-196d-4aa7-99b0-ef3ed99a8d31 61 fields · synced Sep 30, 2026
- EUDAMED 23234315-bff9-4d28-9c59-5ec1cffbe15d 61 fields · synced May 17, 2026
- EUDAMED 1dc8876e-2711-49ef-820b-14638412afce 61 fields · synced May 19, 2026
- EUDAMED fd5f5d4a-cbdd-41b2-801f-82be0aa98dfd 61 fields · synced May 19, 2026
- EUDAMED 796d64fc-977a-437f-9e8a-fd83ec35def6 61 fields · synced Sep 17, 2026