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Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test

EUDAMED

Class IVD General (EU MDR)

Ref N/AModel 40 testsModel 25 testsModel 80 testsModel 10 tests

by Beijing Tigsun Diagnostics Co., Ltd.

Identity

Device Name
Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test EUDAMED
Model / Reference
40 tests EUDAMED
N/A EUDAMED
25 tests EUDAMED
80 tests EUDAMED
10 tests EUDAMED

Identifiers

Primary DI / UDI-DI
06973642381353 EUDAMED
06973642381346 EUDAMED
06973642381377 EUDAMED
06973642381322 EUDAMED
Basic UDI-DI
B-06973642381353 EUDAMED
B-06973642381346 EUDAMED
B-06973642381377 EUDAMED
B-06973642381322 EUDAMED
EMDN Code
W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test by Beijing Tigsun Diagnostics Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Beijing Tigsun Diagnostics Co., Ltd.
EUDAMED SRN
CN-MF-000034480
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (4)

  • EUDAMED 81c50ac4-b9b1-4a2a-a28e-58fb8b41add9 61 fields · synced Jul 21, 2026
  • EUDAMED f26bb230-b650-4c7a-a690-6673cf8df685 61 fields · synced May 18, 2026
  • EUDAMED ed4977aa-a558-48be-88d8-ad7abfc7968d 61 fields · synced May 18, 2026
  • EUDAMED 2bb48aa5-8c1b-4384-91d7-ce489944660f 61 fields · synced May 18, 2026