← Back to catalogue

Protein (urine)

EUDAMED

Class IVD General (EU MDR)

Ref 21512Ref 11559Ref 11603Ref 12501Ref 11501

by Biosystems S.a.

Identity

Device Name
PROTEIN (URINE) EUDAMED
PROTEIN (URINE) STANDARD EUDAMED
Model / Reference
21512 EUDAMED
11559 EUDAMED
11603 EUDAMED
12501 EUDAMED
11501 EUDAMED

Identifiers

Primary DI / UDI-DI
08435287102017 EUDAMED
08435287115598 EUDAMED
08435287101775 EUDAMED
08435287125016 EUDAMED
08435287115017 EUDAMED
Basic UDI-DI
B-08435287102017 EUDAMED
B-08435287115598 EUDAMED
B-08435287101775 EUDAMED
B-08435287125016 EUDAMED
B-08435287115017 EUDAMED
EMDN Code
W01010299 SUBSTRATES - OTHER EUDAMED
W0101050301 CALIBRATORS MULTICOMPONENT (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

No

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

New Device

No

EUDAMED

Protein (urine) by Biosystems S.a. — 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

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

Manufacturer

Manufacturer
Biosystems S.a.
EUDAMED SRN
ES-MF-000000231

Sources (5)

  • EUDAMED 20efd7d3-ac98-4b07-bd87-edec5da2dd28 61 fields · synced Jul 19, 2026
  • EUDAMED 4363bf78-8a5c-44b8-a112-58b7c683f482 61 fields · synced May 17, 2026
  • EUDAMED d97f80d8-872a-4454-aed0-553fc492a3b4 61 fields · synced May 17, 2026
  • EUDAMED 2c61d7c8-37e1-423c-89d1-75049add2492 61 fields · synced May 18, 2026
  • EUDAMED 3c5765b8-4622-4b0a-96e8-ead0656d9260 61 fields · synced May 18, 2026