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TPU Films

by Zhongshan Breathtex Speciality Material Co., Ltd

Ref 2580SFModel 2580SF,2582N,2582N-D,BT2390X,EL1801N-ZG,EL2011A,EL2201N-PET,EL2201N-ZG,EL2245S-PP,EL2501N-PE,EL2505N-PE,EL2565,EL2582N,EL2586-PE, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698003264TF001AC Basic UDI-DI 06980032640020UDI-DIDate24 Jul 2026RegisteredStatusActive

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  • Withdrawn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
TPU Films
Model / Reference
2580SF, 2582N, 2582N-D, BT2390X, EL1801N-ZG, EL2011A, EL2201N-PET, EL2201N-ZG, EL2245S-PP, EL2501N-PE, EL2505N-PE, EL2565, EL2582N, EL2586-PE, etc.
Primary DI / UDI-DI
06980032640020
Basic UDI-DI
698003264TF001AC
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000011465
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhongshan Breathtex Speciality Material Co., Ltd

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