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Disposable Endoscopic Specimen Retrieval Bags
EUDAMEDClass IIa (EU MDR)
Ref FH03Model HT SeriesModel FT SeriesModel FR SeriesModel HR Series
Identity
- Trade Name
- Disposable Endoscopic Specimen Retrieval Bags EUDAMED
- Device Name
- Disposable Endoscopic Specimen Retrieval Bags EUDAMED
- Model / Reference
- HT Series EUDAMEDFH03 EUDAMEDFT Series EUDAMEDFR Series EUDAMEDHR Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348300352 EUDAMED06921348300444 EUDAMED06921348300260 EUDAMED06921348300185 EUDAMED
- Basic UDI-DI
- 69213483FH0303R62 EUDAMED69213483FH0304R65 EUDAMED69213483FH0302R5X EUDAMED69213483FH0301E52 EUDAMED
- EMDN Code
- K01020120 MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, 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 Specimen Retrieval Bags 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 | 69213483FH0303R62 | 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 (4)
- EUDAMED 9226abd3-c4af-4e63-8447-bcde53eb8ba2 61 fields · synced Jul 29, 2026
- EUDAMED 1f896620-2917-4124-ba16-adf21635229e 61 fields · synced May 17, 2026
- EUDAMED ad9157f5-1508-4c22-89ed-f66a47ef324a 61 fields · synced May 18, 2026
- EUDAMED 63b4e946-daf7-4f59-83b4-6471bae693b2 61 fields · synced May 19, 2026