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Dry Imaging Film

by Shenzhen Fanhao Technology Co., Ltd

Ref FH-X 8x10inchModel FH-X 8x10inch, FH-X 10x12inch, FH-X 10x14inch, FH-X 11x14in, FH-X 14x17inch; FH-A 8x10inch, FH-A 10x12inch, FH-A 10x14inch, FH-A 11x14in, FH-A 14x17inch; DI-HL 8x10inch, 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 Number697765628DIF001NJ Basic UDI-DI 06977656280008UDI-DIDate30 Jul 2024RegisteredStatusActive

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  • Withdrawn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
Dry Imaging Film
Model / Reference
FH-X 8x10inch, FH-X 10x12inch, FH-X 10x14inch, FH-X 11x14in, FH-X 14x17inch, FH-A 8x10inch, FH-A 10x12inch, FH-A 10x14inch, FH-A 11x14in, FH-A 14x17inch, DI-HL 8x10inch, etc
Primary DI / UDI-DI
06977656280008
Basic UDI-DI
697765628DIF001NJ
EMDN Code
T030102 Cover sheaths, instruments and equipments
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042422
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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