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DNlite-IVD103

EUDAMED

Class B (EU MDR)

Ref 8103106 (-20oC)Ref 8103106 (4oC)Ref DNlite-IVD103

by Bio Preventive Medicine Corp.

Identity

Trade Name
DNlite-IVD103 EUDAMED
Device Name
DNlite uPTM-FetA ELISA Kit EUDAMED
Human uPTM3-DKD ELISA EUDAMED
Model / Reference
8103106 (-20oC) EUDAMED
8103106 (4oC) EUDAMED
DNlite-IVD103 EUDAMED

Identifiers

Primary DI / UDI-DI
04719879490053 EUDAMED
04719879490664 EUDAMED
D-4719879490015D9 EUDAMED
Basic UDI-DI
471987949E103017J EUDAMED
B-4719879490015D9 EUDAMED
EMDN Code
W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
W010399 HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED

Classification

Device Class
Class B EUDAMED
Class IVD General EUDAMED
Market of Registration
Czechia EUDAMED
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

DNlite-IVD103 by Bio Preventive Medicine Corp. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Bio Preventive Medicine Corp.
EUDAMED SRN
TW-MF-000022845
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED ed315e0d-b885-45c4-8524-1edbbd03bf0c 61 fields · synced Jul 28, 2026
  • EUDAMED e138ef43-712b-413f-88d4-a5c30df62219 61 fields · synced May 18, 2026
  • EUDAMED abb65cbd-4ce7-4e85-94a1-c208ead56b9a 61 fields · synced May 18, 2026