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COVID-19 (SARS-CoV-2) Antigen Test Kit

EUDAMED

Class IVD General (EU MDR)

Ref W-Ag07-B20Model Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (short version)) Ref W-Ag06-B20Model Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (long version))Ref W-Ag08-B20Model Type:B-20,20 Tests/kit (Positive control)Ref W-Ag06-C10Ref W-Ag05-C01Ref W-Ag08-C01Ref W-Ag02-C01Ref W-Ag05-C10Ref W-Ag04-B20Model Type:B-20,20 Tests/kit (Anterior nasal swab)Ref W-Ag01-B10Model Type:B-10,10 Tests/kit (Anterior nasal swab (short version))Ref W-Ag02-C10Model W-Ag02-C10,Ref W-Ag02-B05Model Type:B-5,5 Tests/kit (Throat swab)Ref W-Ag01-B01Ref W-Ag02-B10Model Type:B-10,10 Tests/kit(Throat swab) Ref W-Ag05-B20Model Type:B-20,20 Tests/kit (Nasal swab + throat swab)Ref W-Ag09-B01Ref W-Ag01-C05Ref W-Ag04-B10Model Type:B-10,10 Tests/kit (Anterior nasal swab)Ref W-Ag08-C20Model Type:C-20, 20Tests/kit (Positive control)Ref W-Ag04-C20Model Type:C-20, 20Tests/kit (Anterior nasal swab)Ref W-Ag01-B20Model Type:B-20,20 Tests/kit(Anterior nasal swab (short version)) Ref W-Ag09-B10Model Type:B-10,10 Tests/kit ( Positive and negative controls)Ref W-Ag09-C05Ref W-Ag05-B01Model Type:B-1,1 Test/kit (Nasal swab + throat swab)Ref W-Ag09-C01Ref W-Ag05-C05Model Type:C-5, 5Tests/kit (Nasal swab + throat swab)Ref W-Ag03-01Model Type:A-1,1 Test/kit （Nasal swab）Ref W-Ag07-C20Model Type:C-20, 20Tests/kit(Nasal swab + anterior nasal swab (short version)) Ref W-Ag03-B10Model Type:B-10,10 Tests/kit (Nasal swab)Ref W-Ag05-B05Model Type:B-5,5 Tests/kit (Nasal swab + throat swab)Ref W-Ag05-01Model Type:A-1,1 Test/kit (Nasal swab + throat swab)Ref W-Ag06-01Model Type:A-1,1 Test/kit (Nasal swab + anterior nasal swab (long version)) Ref W-Ag07-B10Model Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (short version))Ref W-Ag04-C10Ref W-Ag01-C01Ref W-Ag04-C05Ref W-Ag01-C20Model Type:C-20, 20Tests/kit (Anterior nasal swab (short version))Ref W-Ag06-B01Model Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short versionNasal swab + anterior nasal swab (long version))Ref W-Ag07-B05Model Type:B-5,5 Tests/kit (Nasal swab + anterior nasal swab (short version))Ref W-Ag08-B05Model Type:B-5,5 Tests/kit (Positive control)Ref W-Ag02-B20Model Type:B-20,20 Tests/kit (Throat swab)Ref W-Ag03-C01Ref W-Ag09-C20Ref W-AgH-20Model Type:B-20 Tests/KitRef W-AgH-25SModel Type:B-25 Tests/Kit Type SRef W-AgH-15Model Type:B-15 Tests/KitRef W-AgH-20SModel Type:B-20 Tests/Kit Type SRef W-AgH-10SModel Type:B-10 Tests/Kit Type SRef W-AgH-15SModel Type:B-15 Tests/Kit Type SRef W-AgH-02Model Type:B-2 Tests/KitRef W-AgH-05SModel Type:B-5 Tests/Kit Type S

by Wuhan Easydiagnosis Biomedicine Co., Ltd.

Identity

Trade Name
COVID-19 (SARS-CoV-2) Antigen Test Kit EUDAMED
COVID-19(SARS-CoV-2) Antigen Test Kit EUDAMED
Device Name
COVID-19 (SARS-CoV-2) Antigen Test Kit EUDAMED
COVID-19(SARS-CoV-2) Antigen Test Kit EUDAMED
Model / Reference
Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (short version)) EUDAMED
W-Ag07-B20 EUDAMED
Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (long version)) EUDAMED
W-Ag06-B20 EUDAMED
Type:B-20,20 Tests/kit (Positive control) EUDAMED
W-Ag08-B20 EUDAMED
W-Ag06-C10 EUDAMED
W-Ag05-C01 EUDAMED
W-Ag08-C01 EUDAMED
W-Ag02-C01 EUDAMED
W-Ag05-C10 EUDAMED
Type:B-20,20 Tests/kit (Anterior nasal swab) EUDAMED
W-Ag04-B20 EUDAMED
Type:B-10,10 Tests/kit (Anterior nasal swab (short version)) EUDAMED
W-Ag01-B10 EUDAMED
W-Ag02-C10, EUDAMED
W-Ag02-C10 EUDAMED
Type:B-5,5 Tests/kit (Throat swab) EUDAMED
W-Ag02-B05 EUDAMED
W-Ag01-B01 EUDAMED
Type:B-10,10 Tests/kit(Throat swab) EUDAMED
W-Ag02-B10 EUDAMED
Type:B-20,20 Tests/kit (Nasal swab + throat swab) EUDAMED
W-Ag05-B20 EUDAMED
W-Ag09-B01 EUDAMED
W-Ag01-C05 EUDAMED
Type:B-10,10 Tests/kit (Anterior nasal swab) EUDAMED
W-Ag04-B10 EUDAMED
Type:C-20, 20Tests/kit (Positive control) EUDAMED
W-Ag08-C20 EUDAMED
Type:C-20, 20Tests/kit (Anterior nasal swab) EUDAMED
W-Ag04-C20 EUDAMED
Type:B-20,20 Tests/kit(Anterior nasal swab (short version)) EUDAMED
W-Ag01-B20 EUDAMED
Type:B-10,10 Tests/kit ( Positive and negative controls) EUDAMED
W-Ag09-B10 EUDAMED
W-Ag09-C05 EUDAMED
Type:B-1,1 Test/kit (Nasal swab + throat swab) EUDAMED
W-Ag05-B01 EUDAMED
W-Ag09-C01 EUDAMED
Type:C-5, 5Tests/kit (Nasal swab + throat swab) EUDAMED
W-Ag05-C05 EUDAMED
Type:A-1,1 Test/kit （Nasal swab） EUDAMED
W-Ag03-01 EUDAMED
Type:C-20, 20Tests/kit(Nasal swab + anterior nasal swab (short version)) EUDAMED
W-Ag07-C20 EUDAMED
Type:B-10,10 Tests/kit (Nasal swab) EUDAMED
W-Ag03-B10 EUDAMED
Type:B-5,5 Tests/kit (Nasal swab + throat swab) EUDAMED
W-Ag05-B05 EUDAMED
Type:A-1,1 Test/kit (Nasal swab + throat swab) EUDAMED
W-Ag05-01 EUDAMED
Type:A-1,1 Test/kit (Nasal swab + anterior nasal swab (long version)) EUDAMED
W-Ag06-01 EUDAMED
Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (short version)) EUDAMED
W-Ag07-B10 EUDAMED
W-Ag04-C10 EUDAMED
W-Ag01-C01 EUDAMED
W-Ag04-C05 EUDAMED
Type:C-20, 20Tests/kit (Anterior nasal swab (short version)) EUDAMED
W-Ag01-C20 EUDAMED
Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short versionNasal swab + anterior nasal swab (long version)) EUDAMED
W-Ag06-B01 EUDAMED
Type:B-5,5 Tests/kit (Nasal swab + anterior nasal swab (short version)) EUDAMED
W-Ag07-B05 EUDAMED
Type:B-5,5 Tests/kit (Positive control) EUDAMED
W-Ag08-B05 EUDAMED
Type:B-20,20 Tests/kit (Throat swab) EUDAMED
W-Ag02-B20 EUDAMED
W-Ag03-C01 EUDAMED
W-Ag09-C20 EUDAMED
Type:B-20 Tests/Kit EUDAMED
W-AgH-20 EUDAMED
Type:B-25 Tests/Kit Type S EUDAMED
W-AgH-25S EUDAMED
Type:B-15 Tests/Kit EUDAMED
W-AgH-15 EUDAMED
Type:B-20 Tests/Kit Type S EUDAMED
W-AgH-20S EUDAMED
Type:B-10 Tests/Kit Type S EUDAMED
W-AgH-10S EUDAMED
Type:B-15 Tests/Kit Type S EUDAMED
W-AgH-15S EUDAMED
Type:B-2 Tests/Kit EUDAMED
W-AgH-02 EUDAMED
Type:B-5 Tests/Kit Type S EUDAMED
W-AgH-05S EUDAMED

Identifiers

Primary DI / UDI-DI
06978896416493 EUDAMED
06978896416509 EUDAMED
06978896416486 EUDAMED
06978896416950 EUDAMED
06978896417230 EUDAMED
06978896417209 EUDAMED
06978896417261 EUDAMED
06978896416967 EUDAMED
06978896416523 EUDAMED
06978896416646 EUDAMED
06978896416998 EUDAMED
06978896416721 EUDAMED
06978896416820 EUDAMED
06978896416639 EUDAMED
06978896416516 EUDAMED
06978896416745 EUDAMED
06978896417094 EUDAMED
06978896416615 EUDAMED
06978896416844 EUDAMED
06978896416882 EUDAMED
06978896416554 EUDAMED
06978896416561 EUDAMED
06978896417018 EUDAMED
06978896416783 EUDAMED
06978896417193 EUDAMED
06978896417056 EUDAMED
06978896416448 EUDAMED
06978896416851 EUDAMED
06978896416622 EUDAMED
06978896416691 EUDAMED
06978896416424 EUDAMED
06978896416417 EUDAMED
06978896416585 EUDAMED
06978896416974 EUDAMED
06978896417278 EUDAMED
06978896417063 EUDAMED
06978896416912 EUDAMED
06978896416776 EUDAMED
06978896416677 EUDAMED
06978896416660 EUDAMED
06978896416547 EUDAMED
06978896417254 EUDAMED
06978896416837 EUDAMED
06978896417698 EUDAMED
06978896417704 EUDAMED
06978896417674 EUDAMED
06978896417681 EUDAMED
06978896417643 EUDAMED
06978896417667 EUDAMED
06978896417575 EUDAMED
06978896417582 EUDAMED
Basic UDI-DI
B-06978896416493 EUDAMED
B-06978896416509 EUDAMED
B-06978896416486 EUDAMED
B-06978896416950 EUDAMED
B-06978896417230 EUDAMED
B-06978896417209 EUDAMED
B-06978896417261 EUDAMED
B-06978896416967 EUDAMED
B-06978896416523 EUDAMED
B-06978896416646 EUDAMED
B-06978896416998 EUDAMED
B-06978896416721 EUDAMED
B-06978896416820 EUDAMED
B-06978896416639 EUDAMED
B-06978896416516 EUDAMED
B-06978896416745 EUDAMED
B-06978896417094 EUDAMED
B-06978896416615 EUDAMED
B-06978896416844 EUDAMED
B-06978896416882 EUDAMED
B-06978896416554 EUDAMED
B-06978896416561 EUDAMED
B-06978896417018 EUDAMED
B-06978896416783 EUDAMED
B-06978896417193 EUDAMED
B-06978896417056 EUDAMED
B-06978896416448 EUDAMED
B-06978896416851 EUDAMED
B-06978896416622 EUDAMED
B-06978896416691 EUDAMED
B-06978896416424 EUDAMED
B-06978896416417 EUDAMED
B-06978896416585 EUDAMED
B-06978896416974 EUDAMED
B-06978896417278 EUDAMED
B-06978896417063 EUDAMED
B-06978896416912 EUDAMED
B-06978896416776 EUDAMED
B-06978896416677 EUDAMED
B-06978896416660 EUDAMED
B-06978896416547 EUDAMED
B-06978896417254 EUDAMED
B-06978896416837 EUDAMED
B-06978896417698 EUDAMED
B-06978896417704 EUDAMED
B-06978896417674 EUDAMED
B-06978896417681 EUDAMED
B-06978896417643 EUDAMED
B-06978896417667 EUDAMED
B-06978896417575 EUDAMED
B-06978896417582 EUDAMED
EMDN Code
W0105041101 CORONAVIRUS AG EUDAMED
W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class IVD devices for self-testing EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMEDEUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

COVID-19 (SARS-CoV-2) Antigen Test Kit by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Wuhan Easydiagnosis Biomedicine Co., Ltd.
EUDAMED SRN
CN-MF-000019908
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (51)

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