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Biocomma

EUDAMED

Class A (EU MDR)

Ref CJ005-50-03Model CJ005-36-01

by Biocomma Limited

Identity

Trade Name
Biocomma EUDAMED
Device Name
Cell Preservation Solution EUDAMED
Model / Reference
CJ005-36-01 EUDAMED
CJ005-50-03 EUDAMED

Identifiers

Primary DI / UDI-DI
16974660730403 EUDAMED
Basic UDI-DI
697466073P10RY EUDAMED
EMDN Code
W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

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

Category: General specimen container IVD, no additive/medium

Biocomma by Biocomma Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Biocomma Limited
EUDAMED SRN
CN-MF-000013631
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 4d1e6e0b-15f0-44a9-afad-f1136f05d76f 61 fields · synced Jun 18, 2026