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by Toruńskie Zakłady Materiałów Opatrunkowych Spółka Akcyjna 332 variants

Ref PR-199-MIS1-001, OM-194-FPPR-017, OM-191-FWPA-013, PR-195-K060-005, OM-191-FPPA-123, OM-191-FPPR-025, OM-191-FPPR-020, PR-195-MIX1-004, OM-195-K060-008, OM-191-FPPA-131, OM-194-FPPR-005, OM-191-FPPR-029, OM-194-FPPA-008, OM-191-FPPA-153, PR-194-FPPA-052, PR-199-MIS2-004, PR-191-FPSA-048, OM-191-FPFA-031, OM-191-FPPA-263, OM-195-MIX1-008, PR-195-B060-008, OM-191-FPPR-040, PR-191-FPSA-023, OM-199-Z040-007, PR-191-FPFA-013, OM-191-FPFA-010, OM-194-FPPR-015, PR-199-Z060-016, OM-194-FPPR-008, PR-195-B060-009, PR-194-FPFA-030, PR-199-N040-019, OM-191-FPPA-456, OM-191-FWPA-008, PR-194-FPPA-021, PR-191-FPPA-429, OM-194-FPPA-P17, PR-191-FPPA-130, PR-194-FPFA-026, OM-191-FPFA-015, OM-191-FPPA-414, PR-191-FPPA-133, OM-194-TYPA-012, OM-191-FPPA-410, OM-191-FPPR-015, PR-199-Z060-015, OM-195-K060-006, OM-195-K060-002, OM-191-FPPA-433, PR-195-B060-007, OM-191-FPPA-136

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 Number5900516AAEXXXXSB Basic UDI-DI Date29 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  • Withdrawn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

Device Name
Medical Packaging
Model / Reference
PR-199-MIS1-001, OM-194-FPPR-017, OM-191-FWPA-013, PR-195-K060-005, OM-191-FPPA-123, OM-191-FPPR-025, OM-191-FPPR-020, PR-195-MIX1-004, OM-195-K060-008, OM-191-FPPA-131, OM-194-FPPR-005, OM-191-FPPR-029, OM-194-FPPA-008, OM-191-FPPA-153, PR-194-FPPA-052, PR-199-MIS2-004, PR-191-FPSA-048, OM-191-FPFA-031, OM-191-FPPA-263, OM-195-MIX1-008, PR-195-B060-008, OM-191-FPPR-040, PR-191-FPSA-023, OM-199-Z040-007, PR-191-FPFA-013, OM-191-FPFA-010, OM-194-FPPR-015, PR-199-Z060-016, OM-194-FPPR-008, PR-195-B060-009, PR-194-FPFA-030, PR-199-N040-019, OM-191-FPPA-456, OM-191-FWPA-008, PR-194-FPPA-021, PR-191-FPPA-429, OM-194-FPPA-P17, PR-191-FPPA-130, PR-194-FPFA-026, OM-191-FPFA-015, OM-191-FPPA-414, PR-191-FPPA-133, OM-194-TYPA-012, OM-191-FPPA-410, OM-191-FPPR-015, PR-199-Z060-015, OM-195-K060-006, OM-195-K060-002, OM-191-FPPA-433, PR-195-B060-007, OM-191-FPPA-136
Primary DI / UDI-DI
05900516327545, 05900516934385, 05900516503253, 05900516197360, 05900516500498, 05900516501891, 05900516501846, 05900516197445, 05900516913793, 05900516500573, 05900516502010, 05900516501938, 05900516500085, 05900516503406, 05900516331429, 05900516327613, 05900516724559, 05900516506971, 05900516507244, 05900516947361, 05900516197216, 05900516505264, 05900516724436, 05900516507411, 05900516723873, 05900516500764, 05900516502102, 05900516106850, 05900516502041, 05900516197223, 05900516724245, 05900516024765, 05900516505035, 05900516500986, 05900516723682, 05900516723729, 05900516503611, 05900516726201, 05900516724207, 05900516500726, 05900516503246, 05900516726232, 05900516503758, 05900516503215, 05900516501792, 05900516044299, 05900516913779, 05900516913731, 05900516504106, 05900516197209, 05900516500627
Basic UDI-DI
5900516AAEXXXXSB
EMDN Code
S010302, S01020101, S010199, S010301, S01010101, S01010102, S01020102, S01020201
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000002200

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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