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Globy

by Supermax Glove Manufacturing Sdn Bhd 10 variants

Ref M

Globy (M) is a Class I device made by Supermax Glove Manufacturing Sdn Bhd, registered in EUDAMED on 24 Jun 2025 (Basic UDI-DI 955100345124B5), 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 Number955100345124B5 Basic UDI-DI 09551025332399UDI-DIDate24 Jun 2025RegisteredStatusActive

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  • Withdrawn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

Device name
Powder Free Nitrile Examination Gloves
Model / reference
M
Primary DI / UDI-DI
09551025332399
Basic UDI-DI
955100345124B5
EMDN code
T01020204 Nitrile examination / treatment gloves
Device class
Class I
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
MY-MF-000016722
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Other properties (14, all answered No)