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myplant

by Hager & Meisinger GmbH EUDAMEDGUDID

Active European Union

Ref XRP01, PAP52, PUPM1, PAP03, PAP01, PAP02, XUP01, PAP05, PRP02, PAP51, PSB21, XSB11, YAB22, PMU01, KTB02, YTB03, XTBC3, KAB03, B4595, KTB04, XAB56, YAB06, XAB03, PVS00, K4011, A3580, M4080, YTBC2, PPMB3, K4080, K4514, XTB04, YTB02, ZRA02, YAB51, PAB05, KAB51, PKA01, PAB76, K4511, PSA01, PSA12, KAB53, K3511Model Accessories for prothetic parts, Prosthetic abutment systems, myplant two Dental Implant, myplant bio Dental Implant, Accessories implantology and oral surgery

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number44911220651 Date12 Aug 2025IssuedStatusActive expires 6 Mar 2029
United StatesGUDID listing GUDID NumberE0HMXRP011 UDI-DIDate2 Aug 2019ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 44911220651 Active Supplemented

    Quality management system EU MDR

    Notified body
    0044
    Issued
    12 Aug 2025
    Expires
    6 Mar 2029
    Reason
    Other

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
myplant EUDAMED
myplant two Implant System GUDID
Generic Name
Screw endosteal dental implant, two-piece
Dental torque wrench
Model / Ref / Catalog
Accessories for prothetic parts, XRP01, PAP52, PUPM1, PAP03, PAP01, PAP02, XUP01, PAP05, PRP02, PAP51, PSB21, XSB11, M4080, B4595, A3580, ZRA02, Prosthetic abutment systems, YAB22, PMU01, KTB02, YTB03, XTBC3, KAB03, myplant two Dental Implant, KTB04, XAB56, YAB06, XAB03, PVS00, myplant bio Dental Implant, K4011, YTBC2, PPMB3, K4080, K4514, XTB04, YTB02, Accessories implantology and oral surgery, YAB51, PAB05, KAB51, PKA01, PAB76, K4511, PSA01, PSA12, KAB53, K3511, ZHS01, B4580, M4095
Primary DI / UDI-DI
E0HMXRP011, E0HMPAP521, E0HMPUPM11, E0HMPAP031, E0HMPAP011, E0HMPAP021, E0HMXUP011, E0HMPAP051, E0HMPRP021, E0HMPAP511, E0HMPSB211, E0HMXSB111, E0HMM40801, E0HMB45951, E0HMA35801, E0HMZRA021, E0HMYAB221, E0HMPMU011, E0HMKTB021, E0HMYTB031, E0HMXTBC31, E0HMKAB031, E0HMKTB041, E0HMXAB561, E0HMYAB061, E0HMXAB031, E0HMPVS001, E0HMK40111, E0HMYTBC21, E0HMPPMB31, E0HMK40801, E0HMK45141, E0HMXTB041, E0HMYTB021, E0HMYAB511, E0HMPAB051, E0HMKAB511, E0HMPKA011, E0HMPAB761, E0HMK45111, E0HMPSA011, E0HMPSA121, E0HMKAB531, E0HMK35111, E0HMZHS011, E0HMB45801, E0HMM40951
Basic UDI-DI
++E0HM311I00ABM6, ++E0HM311I05ACMZ, ++E0HM311I02ACMJ, ++E0HM311I02ABMG, ++E0HM305IIB01AB3A, ++E0HM305IIB00AA33, ++E0HM270IIB00AA48, ++E0HM271IIB00AA4T, ++E0HM351I07AOR7
Direct Marketing DI
E0HMZRA021
510(k) Number
FDA Product Code
DZE, DZN
EMDN Code
Q010280, P01020180, P01020101, Q0199
GMDN Term
Screw endosteal dental implant, two-piece
Dental torque wrench
Device Class
Class I EUDAMEDGUDID
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640, 872.4565
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIb
GUDID
Class I
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000004966

Other devices from Hager & Meisinger GmbH

See all devices from Hager & Meisinger GmbH →

Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Single Use YesGUDIDNoGUDID
  • Implantable NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Sutures
  • Prescription Use
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date YesGUDIDNoGUDID

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No