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A501-2

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref A-501-2Model A501-2

by Zhejiang Haisheng Medical Device Co., Ltd.

Identity

Trade Name
Disposable Bacterial/Viral Filter FDA UDI
Generic Name
Microbial medical gas filter, single-use FDA UDI
Device Name
A501-2 EUDAMED
Model / Reference
A501-2 EUDAMEDFDA UDI
A-501-2 EUDAMED

Identifiers

Primary DI / UDI-DI
06944375300102 EUDAMEDFDA UDI
Basic UDI-DI
B-06944375300102 EUDAMED
FDA Product Code
CAH FDA UDI
EMDN Code
R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
GMDN Term
Microbial medical gas filter, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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

A501-2 by Zhejiang Haisheng Medical Device Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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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 60b0d7a1-9340-4539-972c-ad397e65a30e 61 fields · synced Jul 9, 2026
  • FDA UDI cbc7e01e-1499-4ab2-89f3-42ba21958209 32 fields · synced May 30, 2026