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Surgicare Premier

by Kanam Latex Industries Private Limited 29 variants

Ref CHGYN PW 7.5, 214L02E65, 216122, 216X02E65, 214L02E85, 216124, 216126, 003/7.0, 003/6.0, 054/5.5, 003S04E70, 003/6.5, 003/8.0, 054/7.0, 216X02E85, 019S04E85, 003/9.0, 019S04E75, 003S04E90, 216X03R75, 019S04E65, 003/7.5, 003S04E75, 019S04E70, 216X02E75, 003S04E85

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number806363LSGFM4 Basic UDI-DI Date17 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Surgicare Premier
Surgicare
Device Name
Sterile Latex Surgical Gloves Powder Free
Sterile Latex Surgical Gloves Powdered
Model / Reference
CHGYN PW 7.5, 214L02E65, 216122, 216X02E65, 214L02E85, 216124, 216126, 003/7.0, 003/6.0, 054/5.5, 003S04E70, 003/6.5, 003/8.0, 054/7.0, 216X02E85, 019S04E85, 003/9.0, 019S04E75, 003S04E90, 216X03R75, 019S04E65, 003/7.5, 003S04E75, 019S04E70, 216X02E75, 003S04E85
Primary DI / UDI-DI
00806363506353, 00806363507084, 00806363506988, 00806363507183, 00806363507107, 00806363506995, 00806363507008, 00806363507442, 00806363507428, 00806363507510, 00806363507947, 00806363507435, 00806363507466, 00806363507541, 00806363025335, 00806363025373, 00806363008970, 00806363507480, 00806363008956, 00806363507985, 00806363503499, 00806363008932, 00806363507459, 00806363507954, 00806363008949, 00806363025359, 00806363507978, 00806363501006, 00806363501303, 00806363025038, 00806363025076, 00806363501204, 00806363501402
Basic UDI-DI
806363LSGFM4, 806363LSGPMQ
EMDN Code
T01010102, T01010101
Device Class
Class IIa
EU market of registration
Italy
France
Greece
Croatia
Lithuania

Manufacturer details

EUDAMED SRN
IN-MF-000022741
Authorised representative
Amstermed B.V. NL-AR-000001971

From the manufacturer

Manufacturer's product page: Surgicare Premier

Other devices from Kanam Latex Industries Private Limited

See all devices from Kanam Latex Industries Private Limited →

Properties

  • Sterile
  • Contains Latex

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No