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Disposable Endoscopic Specimen Retrieval Bags
EUDAMEDClass IIa (EU MDR)
Ref FH03Model HT Series
Identity
- Trade Name
- Disposable Endoscopic Specimen Retrieval Bags EUDAMED
- Device Name
- Disposable Endoscopic Specimen Retrieval Bags EUDAMED
- Model / Reference
- HT Series EUDAMEDFH03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348300369 EUDAMED
- Basic UDI-DI
- 69213483FH0303E58 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 | 69213483FH0303E58 | 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 14303457-09bd-4cd6-8596-6d553221631e 61 fields · synced Jun 19, 2026