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Complement Component 3 Assay Kit (Immunoturbidimetric Method)

EUDAMED

Class IVD General (EU MDR)

Ref DTSH090610Model R1: 60mL×4; R2: 15mL×4Ref DTSH090606Model R1: 40mL×1; R2: 10mL×1Ref DTSH090608Model R1: 40mL×4; R2: 10mL×4

by Da Te Bioengineering Technology Co., LTD.

Identity

Device Name
Complement Component 3 Assay Kit (Immunoturbidimetric Method) EUDAMED
Model / Reference
R1: 60mL×4; R2: 15mL×4 EUDAMED
DTSH090610 EUDAMED
R1: 40mL×1; R2: 10mL×1 EUDAMED
DTSH090606 EUDAMED
R1: 40mL×4; R2: 10mL×4 EUDAMED
DTSH090608 EUDAMED

Identifiers

Primary DI / UDI-DI
06975225463050 EUDAMED
06975225463012 EUDAMED
06975225463036 EUDAMED
Basic UDI-DI
B-06975225463050 EUDAMED
B-06975225463012 EUDAMED
B-06975225463036 EUDAMED
EMDN Code
W0102010203 COMPLEMENT COMPONENT C3/C3C EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

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

Complement Component 3 Assay Kit (Immunoturbidimetric Method) by Da Te Bioengineering Technology 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
Da Te Bioengineering Technology Co., LTD.
EUDAMED SRN
CN-MF-000028832
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED f8321da6-c6ba-450f-a087-4961feb8bff5 61 fields · synced Jul 15, 2026
  • EUDAMED a068b926-6f28-4caa-ad43-956e01aed731 61 fields · synced May 17, 2026
  • EUDAMED 2f539a2a-7b0c-4166-b9a0-91ba0f729701 61 fields · synced May 17, 2026