Paradevice

EUDAMED

Class A (EU MDR)

Ref 110-007

by Reingenuity Ltd

Identity

Trade Name: Paradevice EUDAMED
Device Name: Stool Sampling and Fixing device EUDAMED
Paradevice Stool Sampling and Fixing device EUDAMED
Model / Reference: 110-007 EUDAMED

Identifiers

Primary DI / UDI-DI: 00850085309266 EUDAMED
Basic UDI-DI: 00850085309001007TP EUDAMED
EMDN Code: W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Category: General specimen collection kit

Paradevice by Reingenuity Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	00850085309001007TP	Class A	Active

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Manufacturer

Manufacturer: Reingenuity Ltd
EUDAMED SRN: UK-MF-000052788
Authorised Representative: Eurolink Europe Compliance Limited IE-AR-000002852

Sources (2)

EUDAMED 98355714-9111-4e37-b8e1-fb1b42508bd1 61 fields · synced Jul 17, 2026
EUDAMED fdfe2500-48e5-4dcf-a0b6-bc4101c7beb7 61 fields · synced Jul 17, 2026