← Back to catalogue

KEYU Dry Chemistry Urine analysis Control

EUDAMED

Class IVD General (EU MDR)

Ref NO.IIRef NO.IRef NO.III

by Zhuhai Keyu Biological Engineering Co., Ltd

Identity

Trade Name
KEYU Dry Chemistry Urine analysis Control EUDAMED
Device Name
Dry Chemistry Urine analysis Control EUDAMED
Model / Reference
NO.II EUDAMED
NO.I EUDAMED
NO.III EUDAMED

Identifiers

Primary DI / UDI-DI
06974735360514 EUDAMED
06974735360163 EUDAMED
06974735360521 EUDAMED
Basic UDI-DI
B-06974735360514 EUDAMED
B-06974735360163 EUDAMED
B-06974735360521 EUDAMED
EMDN Code
W0101050102 UNASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

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

KEYU Dry Chemistry Urine analysis Control by Zhuhai Keyu Biological Engineering 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
Zhuhai Keyu Biological Engineering Co., Ltd
EUDAMED SRN
CN-MF-000023195
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (6)

  • EUDAMED 3bc49bef-4ae5-414e-af19-add3bc52600d 61 fields · synced Aug 2, 2026
  • EUDAMED 172e85e9-c9a9-4382-b13f-fd23a50f0610 61 fields · synced May 18, 2026
  • EUDAMED 2a0ed4af-e3b7-45d8-9869-4e16b3ecea89 61 fields · synced May 18, 2026
  • EUDAMED 58ed69dd-07c3-426d-a317-c40222ba17a3 61 fields · synced Jul 11, 2026
  • EUDAMED e5dee278-11be-4d19-a52d-8be320ba86b5 61 fields · synced Jul 25, 2026
  • EUDAMED e550d472-19e8-4edc-931b-412cc6846330 61 fields · synced Aug 2, 2026