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Multichamber™

EUDAMED

Class A (EU MDR)

Ref 0010101

by Hopfly Biotech (Huzhou) CO., LTD

Identity

Trade Name
Multichamber™ EUDAMED
Device Name
Viral Transport Medium EUDAMED
Model / Reference
0010101 EUDAMED

Identifiers

Primary DI / UDI-DI
06975181140019 EUDAMED
Basic UDI-DI
6975181140010101HT EUDAMED
EMDN Code
A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

Yes

EUDAMED

Category: General-purpose absorbent tip applicator/swab, single-use

Multichamber™ by Hopfly Biotech (Huzhou) CO., LTD — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose absorbent tip applicator/swab, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000022345
Authorised Representative
Kingsmead Service B.V. NL-AR-000002066

Sources (1)

  • EUDAMED fc8811cf-712c-45bd-8624-e707eba48ff1 61 fields · synced Jun 18, 2026