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SmartFlag by APOLLO

by Apollo Implant Components Spółka Z Ograniczoną Odpowiedzialnością 64 variants

Ref 004.1S10.C-009-M34-20, 004.2S5.F-013-M45, 004.2S5.H-020-M48, 004.1S10.A-028-M48, 004.1S10.C-004-M47, 004.1S10.C-010-M51, 004.1S10.D-014-M43, 004.2S5.E-009-M34-20, 004.1S10.B-007-M48, 004.2S5.H-034-M46, 004.2S5.F-032-M45, 004.1S10.C-001-M44, 004.1S10.A-032-M40, 004.2S5.E-034-M46, 004.1S10.B-001-M45, 004.2S5.F-028-M48, 004.1S10.C-018-M45, 004.1S10.A-034-M46, 004.1S10.B-032-M40, 004.2S5.G-009-M34-45, 004.1S10.D-001-M44, 004.1S10.A-001-M45, 004.1S10.C-014-M43, 004.1S10.C-008-M48, 004.1S10.A-008-M48, 004.2S5.E-028-M48, 004.1S10.B-014-M43, 004.2S5.F-026-M48, 004.1S10.A-001-M44, 004.1S10.C-022-M48, 004.2S5.F-037-M48, 004.1S10.B-025-M48, 004.1S10.D-032-M40, 004.1S10.D-008-M48, 004.2S5.F-007-M48, 004.1S10.A-004-M47, 004.1S10.D-025-M48, 004.1S10.C-054-M48, 004.2S5.G-008-M48, 004.1S10.C-026-M48, 004.1S10.B-013-M45, 004.1S10.D-009-M34-20, 004.2S5.F-004-M47, 004.1S10.C-009-02, 004.2S5.G-037-M48, 004.1S10.A-008-M37, 004.1S10.C-053-M50, 004.1S10.A-032-M45, 004.1S10.D-009-02, 004.2S5.G-025-M48, 004.2S5.H-009-02

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 Number59043474026RN Basic UDI-DI Date5 Mar 2025RegisteredStatusActive

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  • Withdrawn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
SmartFlag by APOLLO
SmartFlag by APOLLO Multi-Unit C
Device Name
Transfer Impression
Model / Reference
004.1S10.C-009-M34-20, 004.2S5.F-013-M45, 004.2S5.H-020-M48, 004.1S10.A-028-M48, 004.1S10.C-004-M47, 004.1S10.C-010-M51, 004.1S10.D-014-M43, 004.2S5.E-009-M34-20, 004.1S10.B-007-M48, 004.2S5.H-034-M46, 004.2S5.F-032-M45, 004.1S10.C-001-M44, 004.1S10.A-032-M40, 004.2S5.E-034-M46, 004.1S10.B-001-M45, 004.2S5.F-028-M48, 004.1S10.C-018-M45, 004.1S10.A-034-M46, 004.1S10.B-032-M40, 004.2S5.G-009-M34-45, 004.1S10.D-001-M44, 004.1S10.A-001-M45, 004.1S10.C-014-M43, 004.1S10.C-008-M48, 004.1S10.A-008-M48, 004.2S5.E-028-M48, 004.1S10.B-014-M43, 004.2S5.F-026-M48, 004.1S10.A-001-M44, 004.1S10.C-022-M48, 004.2S5.F-037-M48, 004.1S10.B-025-M48, 004.1S10.D-032-M40, 004.1S10.D-008-M48, 004.2S5.F-007-M48, 004.1S10.A-004-M47, 004.1S10.D-025-M48, 004.1S10.C-054-M48, 004.2S5.G-008-M48, 004.1S10.C-026-M48, 004.1S10.B-013-M45, 004.1S10.D-009-M34-20, 004.2S5.F-004-M47, 004.1S10.C-009-02, 004.2S5.G-037-M48, 004.1S10.A-008-M37, 004.1S10.C-053-M50, 004.1S10.A-032-M45, 004.1S10.D-009-02, 004.2S5.G-025-M48, 004.2S5.H-009-02
Primary DI / UDI-DI
05904890600188, 05904890604865, 05904890604568, 05904890600485, 05904890600027, 05904890607255, 05904890604681, 05904890600201, 05904890604988, 05904890600799, 05904890600690, 05904890606531, 05904890600560, 05904890600768, 05904890606609, 05904890600539, 05904890607897, 05904890600720, 05904890600577, 05904890600300, 05904890606548, 05904890606593, 05904890604674, 05904890604599, 05904890604575, 05904890600522, 05904890604667, 05904890600454, 05904890606517, 05904890608375, 05904890600850, 05904890600331, 05904890600591, 05904890604605, 05904890605022, 05904890600003, 05904890600355, 05904890617469, 05904890604636, 05904890600423, 05904890604827, 05904890600195, 05904890600058, 05904890604759, 05904890600867, 05904890600089, 05904890604896, 05904890600645, 05904890604766, 05904890600386, 05904890604803
Basic UDI-DI
59043474026RN
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023711

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

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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