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Ltek-N61A06-GH005

by Leboo Healthcare Products Limited

Part of a family of 60 devices: see the family page

Ref LTEK-N61A06-GH005Model PP Isolation Gown, PE Coated Isolation Gown, N61P01, Half PE Coated Isolation Gown, SMS Isolation Gown, Surgical Isolation Gown, Patient Gown With Short Sleeve, Patient Gown Without Sleeve, Lab Coat With Velcro, Lab Coat With Press Button,etc

Ltek-N61A06-GH005 is a Class I device made by Leboo Healthcare Products Limited, registered in EUDAMED on 5 Aug 2024 (Basic UDI-DI 697442484L03QB), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697442484L03QB Basic UDI-DI 06974424844424UDI-DIDate5 Aug 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
PP Isolation Gown, PE Coated Isolation Gown, N61P01, Half PE Coated Isolation Gown, SMS Isolation Gown, Surgical Isolation Gown, Patient Gown With Short Sleeve, Patient Gown Without Sleeve, Lab Coat With Velcro, Lab Coat With Press Button, etc, LTEK-N61A06-GH005
Primary DI / UDI-DI
06974424844424
Basic UDI-DI
697442484L03QB
EMDN code
T0299 Protection drapes and garments - other
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008521
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (14, all answered No)