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Vaporized Hydrogen Peroxide Indicator Label

EUDAMED

Class I (EU MDR)

Ref M322 Model M322

by Jiangmen New Era External Use Drug Co., Ltd

Identity

Device Name
Vaporized Hydrogen Peroxide Indicator Label EUDAMED
Model / Reference
M322 EUDAMED

Identifiers

Primary DI / UDI-DI
06944270105116 EUDAMED
Basic UDI-DI
69442701M322LN EUDAMED
EMDN Code
S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Sterilizer/disinfector rack

Vaporized Hydrogen Peroxide Indicator Label by Jiangmen New Era External Use Drug Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Sterilizer/disinfector rack.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000036495
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED a850be7e-1e34-49f1-a2c8-72eaa87c239c 61 fields · synced Jun 18, 2026