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Saline 0.85%

EUDAMED

Class A (EU MDR)

Ref EB0334B

by Oxoid Ltd

Identity

Trade Name
SALINE 0.85% EUDAMED
Device Name
0.85% SALINE EUDAMED
Model / Reference
EB0334B EUDAMED

Identifiers

Primary DI / UDI-DI
05032384027408 EUDAMED
Basic UDI-DI
50323840.85%SalineOLVZ EUDAMED
EMDN Code
W0104010306 CULTURE MEDIA IN BOTTLES EUDAMED

Classification

Device Class
Class A 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

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Saline 0.85% by Oxoid Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Oxoid Ltd
EUDAMED SRN
GB-MF-000016914
Authorised Representative
Thermo Fisher Diagnostics B.V. NL-AR-000013157

Sources (1)

  • EUDAMED dee37563-ad04-429f-9a58-5461bb98be5e 61 fields · synced Jun 18, 2026