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Disposable Bacterial/Viral Filter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A-501-1Model A501-1
Identity
- Trade Name
- Disposable Bacterial/Viral Filter FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- Disposable Bacterial/Viral Filter EUDAMED
- Model / Reference
- A501-1 EUDAMEDFDA UDIA-501-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375300096 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06944375300096 EUDAMED
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Secretion suction kit
Disposable Bacterial/Viral Filter by Zhejiang Haisheng Medical Device Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944375300096 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED c20e822c-5b52-4f48-a67a-3360966cd9c7 61 fields · synced Jun 19, 2026
- FDA UDI ef798401-ef18-4fe5-8349-248fa5978a55 32 fields · synced May 30, 2026