← Back to catalogue

Immunochromogenic Reagent

EUDAMED

Class A (EU MDR)

Ref 4980721Model HIRef 4980733Model ENRef 4980731Ref 4980732Ref 4980723

by Shenzhen Dakewe Bio-engineering Co., Ltd.

Identity

Trade Name
Immunochromogenic Reagent EUDAMED
Device Name
Immunochromogenic Reagent EUDAMED
Model / Reference
HI EUDAMED
4980721 EUDAMED
EN EUDAMED
4980733 EUDAMED
4980731 EUDAMED
4980732 EUDAMED
4980723 EUDAMED

Identifiers

Primary DI / UDI-DI
06977644783429 EUDAMED
06977644783412 EUDAMED
06977644783399 EUDAMED
06977644783405 EUDAMED
06977644783443 EUDAMED
Basic UDI-DI
6977644784980729S EUDAMED
6977644784980739U EUDAMED
EMDN Code
W01030711 IMMUNOHISTOLOGY KITS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Spain 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

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Immunochromogenic Reagent by Shenzhen Dakewe Bio-Engineering 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

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

Manufacturer

Manufacturer
Shenzhen Dakewe Bio-engineering Co., Ltd.
EUDAMED SRN
CN-MF-000002174
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (5)

  • EUDAMED 51f0c544-f3fe-444e-a23f-4b8c0e226a2b 61 fields · synced Aug 2, 2026
  • EUDAMED 58732b15-9763-412d-b296-c397384da3a3 61 fields · synced May 17, 2026
  • EUDAMED 40aafe9a-ae84-4232-8468-808d76f246a0 61 fields · synced May 17, 2026
  • EUDAMED 1bd830c1-f2b1-41da-978c-911896ecf279 61 fields · synced May 17, 2026
  • EUDAMED 101dad1e-dc2f-472d-a3e3-8a19d31e9e65 61 fields · synced May 18, 2026