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Axiom

by anthogyr EUDAMED

Active European Union

Ref TOP40100N3, TXT40100R3, TXT40080R2, OPJD026, TOP40060N1, TPX46100R1, TFLEX-N6-SAAU, TXT46120R2, TOP34120R2, TPX46100R2, OPSHSD23, TOP40160N1, OPFLEX616-AAU, TPX52120R2, TPX40140R1, OPFLEX616-AA, TPX34160R2, TMU0-R, TOP46120R1, TPX46140R2, TFLEX-N6-SAA, TPX40100N2, TOP40140N1, TXT40060N1, TPX40140R3, OPFLEX536-AA, TXT64100R1, TPX40100R1, TS160P-ET, TXT40140N1, TPX34140R2, TPX40140N1, OPFLEX634, TPX34160N1, TXT40160R2, TPX46080R3, OPIM120, AXIN152-27B52, TXT34160R3, TOP40160R2, OPSHSA23, AXIN156-02-B, TXT40080N1, TXT40160N2, OPFLEX416-AAU, TPX40060N3, TXT34100N1, TMU30-R-IN, TOP40120R3, TXT40160N3, AX156-0X-S-ETModel Axiom TL Implant, Gauge, Unitary Non-Sterile Abutment/Base/Coping (Titanium), Healing Screw (ZrN-coated Titanium), Plural Sterile Abutment/Base/Coping (Titanium), Plural Non-Sterile Screw (DLC-coated Titanium), Axiom BL Cover Screw (Titanium), Unitary Non-Sterile Screw (DLC-coated Titanium)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number36633940018QV Basic UDI-DIDate6 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Axiom TL Implant, TOP40100N3, TXT40100R3, TXT40080R2, Gauge, OPJD026, TOP40060N1, TPX46100R1, Unitary Non-Sterile Abutment/Base/Coping (Titanium), TFLEX-N6-SAAU, TXT46120R2, TOP34120R2, TPX46100R2, Healing Screw (ZrN-coated Titanium), OPSHSD23, TOP40160N1, OPFLEX616-AAU, TPX52120R2, TPX40140R1, OPFLEX616-AA, TPX34160R2, Plural Sterile Abutment/Base/Coping (Titanium), TMU0-R, TOP46120R1, TPX46140R2, TFLEX-N6-SAA, TPX40100N2, TOP40140N1, TXT40060N1, TPX40140R3, OPFLEX536-AA, TXT64100R1, TPX40100R1, Plural Non-Sterile Screw (DLC-coated Titanium), TS160P-ET, TXT40140N1, TPX34140R2, TPX40140N1, OPFLEX634, TPX34160N1, TXT40160R2, TPX46080R3, Axiom BL Cover Screw (Titanium), OPIM120, AXIN152-27B52, TXT34160R3, TOP40160R2, OPSHSA23, AXIN156-02-B, TXT40080N1, TXT40160N2, OPFLEX416-AAU, TPX40060N3, TXT34100N1, TMU30-R-IN, TOP40120R3, TXT40160N3, Unitary Non-Sterile Screw (DLC-coated Titanium), AX156-0X-S-ET
Primary DI / UDI-DI
03663394165822, 03663394871037, 03663394870962, 03663394013178, 03663394165662, 03663394003643, 03663394873765, 03663394871327, 03663394003742, 03663394003650, 03663394872744, 03663394165716, 03663394873413, 03663394166942, 03663394166713, 03663394873239, 03663394166676, 03663394481083, 03663394166102, 03663394166829, 03663394873741, 03663394166508, 03663394165709, 03663394870863, 03663394003612, 03663394873222, 03663394871570, 03663394003544, 03663394484077, 03663394871105, 03663394003490, 03663394166461, 03663394873017, 03663394166355, 03663394871204, 03663394166843, 03663394872393, 03663394481960, 03663394870856, 03663394166041, 03663394872126, 03663394169837, 03663394870924, 03663394871174, 03663394873352, 03663394480703, 03663394870627, 03663394872430, 03663394003865, 03663394871181, 03663394484268
Basic UDI-DI
36633940018QV, 36633940039R5, 36633940107QV, 36633940153R4, 36633940008QS, 36633940010QD, 36633940103QM, 36633940110QJ
EMDN Code
P01020101, L159099, P010299
Device Class
Class IIb
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000602

Other devices from Anthogyr Sas

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Properties

Show properties
  • Sterile YesEUDAMEDNoEUDAMED
  • Implantable YesEUDAMEDNoEUDAMED
  • Reusable NoEUDAMEDYesEUDAMED
  • Sutures
Other properties (10)
  • 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