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Biological Indicator

EUDAMED

Class I (EU MDR)

Ref KMNBI0101Model KMNBI0201/KMNBI0101/KMNBI0301/KMNBI0102/KMNBI0401/KMNBI0501/KMNBI0502/KMNBI0503

by Anqing Kangmingna Packaging Co., Ltd

Identity

Device Name
Biological Indicator EUDAMED
Model / Reference
KMNBI0201/KMNBI0101/KMNBI0301/KMNBI0102/KMNBI0401/KMNBI0501/KMNBI0502/KMNBI0503 EUDAMED
KMNBI0101 EUDAMED

Identifiers

Primary DI / UDI-DI
06933401100007 EUDAMED
Basic UDI-DI
69334011KMNBIMB 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

Biological Indicator by Anqing Kangmingna Packaging 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-000025536
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED a3f2dd17-0a63-4d45-b02d-4b4efb7bb4ba 61 fields · synced Jun 19, 2026