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Barrier Covers

by Yongqing Huaguan Dental Instruments Factory

Ref HL-PSModel Pro-Sleeve HL-PS，116490 Barrier film HL-001,HL-002,HL-003,HL-004,HL-005, HL-006,HL-007,HL-008,HL-009,HL-010, HL-011,HL-012,HL-013,HL-014,HL-015,etc

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697933301BC0019Y Basic UDI-DI 06979333010014UDI-DIDate28 Nov 2025RegisteredStatusActive

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  • Withdrawn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
Barrier Covers
Model / Reference
Pro-Sleeve HL-PS，116490 Barrier film HL-001, HL-002, HL-003, HL-004, HL-005, HL-006, HL-007, HL-008, HL-009, HL-010, HL-011, HL-012, HL-013, HL-014, HL-015, etc, HL-PS
Primary DI / UDI-DI
06979333010014
Basic UDI-DI
697933301BC0019Y
EMDN Code
T030199 Covers, instruments and equipment - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000050618
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Yongqing Huaguan Dental Instruments Factory

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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