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Ccts

EUDAMED

Class A (EU MDR)

Ref 6018020207-CERef 6018003302-CERef 6018003303-CERef 6018003304-CERef 6018003305-CERef 6018020204-CERef 6018020205-CERef 6018003306-CE

by Coyote Bioscience Co., Ltd.

Identity

Trade Name
CCTS EUDAMED
Device Name
COYOTE® CCTS™ Respiratory Swab Specimen Collection Kit EUDAMED
Model / Reference
6018020207-CE EUDAMED
6018003302-CE EUDAMED
6018003303-CE EUDAMED
6018003304-CE EUDAMED
6018003305-CE EUDAMED
6018020204-CE EUDAMED
6018020205-CE EUDAMED
6018003306-CE EUDAMED

Identifiers

Primary DI / UDI-DI
06974767390169 EUDAMED
06974767390183 EUDAMED
06974767390190 EUDAMED
06974767390206 EUDAMED
06974767390213 EUDAMED
06974767390138 EUDAMED
06974767390145 EUDAMED
06974767390220 EUDAMED
Basic UDI-DI
6974767396018020208V EUDAMED
6974767396018003308Z EUDAMED
Direct Marketing DI
06974767390169 EUDAMED
06974767390183 EUDAMED
06974767390190 EUDAMED
06974767390206 EUDAMED
06974767390213 EUDAMED
06974767390138 EUDAMED
06974767390145 EUDAMED
06974767390220 EUDAMED
EMDN Code
W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Italy EUDAMED
Sweden EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Ccts by Coyote Bioscience Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000024155
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (8)

  • EUDAMED 7c2234f3-43c8-41f5-9b7e-bb39a0514cf6 61 fields · synced Aug 4, 2026
  • EUDAMED 11abc831-8d73-41ba-9f79-214ee32e999a 61 fields · synced May 17, 2026
  • EUDAMED 0a8ef6b5-da6e-4135-b72d-dd3a4ba4ece4 61 fields · synced May 17, 2026
  • EUDAMED e3945827-bfd7-4667-b00b-29d14548ddb1 61 fields · synced May 17, 2026
  • EUDAMED ed340d54-817e-424f-a47b-0323fa425b91 61 fields · synced May 17, 2026
  • EUDAMED fbe9f954-a68e-424d-9a01-725afe51193a 61 fields · synced May 18, 2026
  • EUDAMED 035cf65a-ca7b-442d-9349-0ca74e2b2923 61 fields · synced May 19, 2026
  • EUDAMED 4704529e-9ef0-45d8-baca-57cb8cd9ba06 61 fields · synced May 19, 2026