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Barbiturate （BAR） Rapid Test（Urine）

EUDAMED

Class IVD General (EU MDR)

Ref BT0105001

by Xiamen Biotime Biotechnology Co., Ltd.

Identity

Trade Name
Barbiturate （BAR） Rapid Test（Urine） EUDAMED
Device Name
Barbiturate （BAR） Rapid Test（Urine） EUDAMED
Model / Reference
BT0105001 EUDAMED

Identifiers

Primary DI / UDI-DI
06933260208173 EUDAMED
Basic UDI-DI
B-06933260208173 EUDAMED
EMDN Code
W0102160503 BARBITURATES - RT & POC 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

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

Barbiturate （BAR） Rapid Test（Urine） by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000012852
Authorised Representative
Medunion S.L. ES-AR-000019366

Sources (2)

  • EUDAMED 5f8e51c9-35fd-45cd-b7c6-d185994d8e3a 61 fields · synced Oct 7, 2026
  • EUDAMED cb2d0e1d-9b96-4050-895f-5084272bd69d 61 fields · synced Jun 18, 2026