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Jednorázová rouška Balerina BFE99

by Balerina-Czech, s.r.o. 70 variants

Ref 8594205377521, 8594205377040, 8594205377033, 8594205376401, 8594205376524, 8594205377262, 8594205376135, 8594205376586, 8594205376067, 8594205376487, 8594205376319, 8594205377064, 8594205377484, 8594205377330, 8594205376197, 8594205377552, 8594205376968, 8594205377019, 8594205377187, 8594205376739, 8594205377590, 8594205376913, 8594205376395, 8594205376463, 8594205377460, 8594205377477, 8594205376203, 8594205376630, 8594205376050, 8594205377170, 8594205377026, 8594205377200, 8594205376128, 8594205376371, 8594205377248, 8594205377057, 8594205376661, 8594205376234, 8594205377491, 8594205377231, 8594205377514, 8594205376562, 8594205376449, 8594205376500, 8594205377415, 8594205377002, 8594205376357, 8594205376579, 8594205376166, 8594205376418, 8594205376296Model BFE99

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 Number859420537BFE99CA Basic UDI-DI Date19 Jan 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  • Withdrawn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

Model / Reference
BFE99, 8594205377521, 8594205377040, 8594205377033, 8594205376401, 8594205376524, 8594205377262, 8594205376135, 8594205376586, 8594205376067, 8594205376487, 8594205376319, 8594205377064, 8594205377484, 8594205377330, 8594205376197, 8594205377552, 8594205376968, 8594205377019, 8594205377187, 8594205376739, 8594205377590, 8594205376913, 8594205376395, 8594205376463, 8594205377460, 8594205377477, 8594205376203, 8594205376630, 8594205376050, 8594205377170, 8594205377026, 8594205377200, 8594205376128, 8594205376371, 8594205377248, 8594205377057, 8594205376661, 8594205376234, 8594205377491, 8594205377231, 8594205377514, 8594205376562, 8594205376449, 8594205376500, 8594205377415, 8594205377002, 8594205376357, 8594205376579, 8594205376166, 8594205376418, 8594205376296
Primary DI / UDI-DI
08594205377521, 08594205377040, 08594205377033, 08594205376401, 08594205376524, 08594205377262, 08594205376135, 08594205376586, 08594205376067, 08594205376487, 08594205376319, 08594205377064, 08594205377484, 08594205377330, 08594205376197, 08594205377552, 08594205376968, 08594205377019, 08594205377187, 08594205376739, 08594205377590, 08594205376913, 08594205376395, 08594205376463, 08594205377460, 08594205377477, 08594205376203, 08594205376630, 08594205376050, 08594205377170, 08594205377026, 08594205377200, 08594205376128, 08594205376371, 08594205377248, 08594205377057, 08594205376661, 08594205376234, 08594205377491, 08594205377231, 08594205377514, 08594205376562, 08594205376449, 08594205376500, 08594205377415, 08594205377002, 08594205376357, 08594205376579, 08594205376166, 08594205376418, 08594205376296
Basic UDI-DI
859420537BFE99CA
Direct Marketing DI
08594205377521
08594205377040
08594205377033
08594205376401
08594205376524
08594205377262
08594205376135
08594205376586
08594205376067
08594205376487
08594205376319
08594205377064
08594205377484
08594205377330
08594205376197
08594205377552
08594205376968
08594205377019
08594205377187
08594205376739
08594205377590
08594205376913
08594205376395
08594205376463
08594205377460
08594205377477
08594205376203
08594205376630
08594205376050
08594205377170
08594205377026
08594205377200
08594205376128
08594205376371
08594205377248
08594205377057
08594205376661
08594205376234
08594205377491
08594205377231
08594205377514
08594205376562
08594205376449
08594205376500
08594205377415
08594205377002
08594205376357
08594205376579
08594205376166
08594205376418
08594205376296
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000050806

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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