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Autoclave Indicator Label

EUDAMED

Class I (EU MDR)

Ref 单层铜版纸 30mm*50mmModel 单层铜版纸 30mm*50mm 单层合成纸 50mm*80mm 双层铜板纸 70mm*100mm Ref N/A

by Jiangmen New Era External Use Drug Co., Ltd

Identity

Device Name
Autoclave Indicator Label EUDAMED
Model / Reference
单层铜版纸 30mm*50mm 单层合成纸 50mm*80mm 双层铜板纸 70mm*100mm EUDAMED
单层铜版纸 30mm*50mm EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06944270103884 EUDAMED
06944270103877 EUDAMED
Basic UDI-DI
69442701M131LD EUDAMED
EMDN Code
S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED
Netherlands 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

Autoclave 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

Manufacturer
Jiangmen New Era External Use Drug Co., Ltd
EUDAMED SRN
CN-MF-000036495
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED b4bdcd48-8ffb-4ade-9c85-bf91c76da23d 61 fields · synced Jul 20, 2026
  • EUDAMED 2228d9bc-2a76-4e83-935a-e9cbae6b8a5d-1 61 fields · synced Jul 20, 2026