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RTFa-14x17in

by Nanyang Clear Science and Technology Co., Ltd.

Ref Z11079007Model RTFa-14x17in（This basic UDI contains RTFa-14x17in, RTFa-11x14in, RTFa-10x12in, RTFa-8x10in）, RTF-14x17in

RTFa-14x17in (Z11079007) is a Class I device made by Nanyang Clear Science and Technology Co., Ltd., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 697185797RTFaYQ), 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 Number697185797RTFaYQ Basic UDI-DI Date6 Nov 2026RegisteredStatusActive

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  • Withdrawn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

Trade name
RTFa-14x17in
RTF-14x17in
Device name
Thermal Film
Model / reference
RTFa-14x17in（This basic UDI contains RTFa-14x17in, RTFa-11x14in, RTFa-10x12in, RTFa-8x10in）, Z11079007, RTF-14x17in
Primary DI / UDI-DI
06971857973882, 06971857973004
Basic UDI-DI
697185797RTFaYQ, 697185797RTFZP
EMDN code
Z11079007 Cassettes for x–ray films
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000051170
Authorised representative
WISELINK MEDICAL, S.L.U. ES-AR-000052118

Similar devices in this category

Other devices filed under VARIOUS SUPPORTING INSTRUMENTS FOR X–RAY FILM IMAGING.

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Properties

Other properties (14, all answered No)