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N65d01-Gs11bf-B03

EUDAMED

Class I (EU MDR)

Ref N65D01-GS11BF-B03Model Microporous Shoe Cover, PE Coated Non-woven Shoe Cover, Half PE Coated Non-woven Shoe Cover, Nonwoven Shoe Cover Machine Made, Nonwoven Shoe Cover Hand Made,Nonwoven Non-Skid Shoe Cover Machine Made, Nonwoven Non-Skid Shoe Cover Hand Made,

by Leboo Healthcare Products Limited

Identity

Model / Reference
Microporous Shoe Cover, PE Coated Non-woven Shoe Cover, Half PE Coated Non-woven Shoe Cover, Nonwoven Shoe Cover Machine Made, Nonwoven Shoe Cover Hand Made,Nonwoven Non-Skid Shoe Cover Machine Made, Nonwoven Non-Skid Shoe Cover Hand Made, EUDAMED
N65D01-GS11BF-B03 EUDAMED

Identifiers

Primary DI / UDI-DI
06974424849665 EUDAMED
06974424848071 EUDAMED
Basic UDI-DI
697442484L06QH EUDAMED
EMDN Code
T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
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

N65d01-Gs11bf-B03 by Leboo Healthcare Products Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Leboo Healthcare Products Limited
EUDAMED SRN
CN-MF-000008521
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED ea4835b2-9945-4056-9fb2-a1fb6614830f 61 fields · synced Oct 6, 2026
  • EUDAMED 139771a9-fdec-4cc4-8762-85d549a50f4a 61 fields · synced May 18, 2026