← Back to catalogue
Majesty-Slc
EUDAMEDClass IIa (EU MDR)
Ref M-100-21-5Model SLC ROTH 018 #21Ref M-100-43H-5Model SLC ROTH 018 #43HRef M-100-35H-5Model SLC ROTH 018 #35HRef 106-553Model SLC ROTH 018 5*5 H345Ref M-100-24H-5Model SLC ROTH 018 #24HRef M-110-43H-5Model SLC ROTH 022 #43HRef M-110-45H-5Model SLC ROTH 022 #45HRef M-130-15H-5Model SLC MBT 022 #15HRef M-110-32-5Model SLC ROTH 022 #32Ref M-110-33H-5Model SLC ROTH 022 #33HRef M-100-31-5Model SLC ROTH 018 #31Ref M-130-14H-5Model SLC MBT 022 #14HRef M-110-23H-5Model SLC ROTH 022 #23HRef M-100-42-5Model SLC ROTH 018 #42Ref M-130-25H-5Model SLC MBT 022 #25HRef M-130-31-5Model SLC MBT 022 #31Ref M-130-44H-5Model SLC MBT 022 #44HRef M-100-13H-5Model SLC ROTH 018 #13HRef M-130-24H-5Model SLC MBT 022 #24HRef M-130-41-5Model SLC MBT 022 #41Ref M-130-35H-5Model SLC MBT 022 #35HRef M-110-12-5Model SLC ROTH 022 #12Ref M-110-25H-5Model SLC ROTH 022 #25HRef M-110-13H-5Model SLC ROTH 022 #13HRef M-130-42-5Model SLC MBT 022 #42Ref 116-331Model SLC ROTH 022 3*3 H3Ref M-130-23H-5Model SLC MBT 022 #23HRef 116-533Model SLC ROTH 022 5*3 H345Ref M-100-11-5Model SLC ROTH 018 #11Ref 106-031Model SLC ROTH 018 0*3 H3 LOWRef 136-331Model SLC MBT 022 3*3 H3Ref M-110-15H-5Model SLC ROTH 022 #15HRef M-110-41-5Model SLC ROTH 022 #41Ref M-130-22-5Model SLC MBT 022 #22Ref M-110-34H-5Model SLC ROTH 022 #34HRef 136-503Model SLC MBT 022 5*0 H345 UPRef M-100-45H-5Model SLC ROTH 018 #45HRef M-110-22-5Model SLC ROTH 022 #22Ref M-130-32-5Model SLC MBT 022 #32Ref 136-301Model SLC MBT 022 3*0 H3 UPRef M-130-21-5Model SLC MBT 022 #21Ref M-100-33H-5Model SLC ROTH 018 #33H
Identity
- Trade Name
- MAJESTY-SLC EUDAMED
- Model / Reference
- SLC ROTH 018 #21 EUDAMEDM-100-21-5 EUDAMEDSLC ROTH 018 #43H EUDAMEDM-100-43H-5 EUDAMEDSLC ROTH 018 #35H EUDAMEDM-100-35H-5 EUDAMEDSLC ROTH 018 5*5 H345 EUDAMED106-553 EUDAMEDSLC ROTH 018 #24H EUDAMEDM-100-24H-5 EUDAMEDSLC ROTH 022 #43H EUDAMEDM-110-43H-5 EUDAMEDSLC ROTH 022 #45H EUDAMEDM-110-45H-5 EUDAMEDSLC MBT 022 #15H EUDAMEDM-130-15H-5 EUDAMEDSLC ROTH 022 #32 EUDAMEDM-110-32-5 EUDAMEDSLC ROTH 022 #33H EUDAMEDM-110-33H-5 EUDAMEDSLC ROTH 018 #31 EUDAMEDM-100-31-5 EUDAMEDSLC MBT 022 #14H EUDAMEDM-130-14H-5 EUDAMEDSLC ROTH 022 #23H EUDAMEDM-110-23H-5 EUDAMEDSLC ROTH 018 #42 EUDAMEDM-100-42-5 EUDAMEDSLC MBT 022 #25H EUDAMEDM-130-25H-5 EUDAMEDSLC MBT 022 #31 EUDAMEDM-130-31-5 EUDAMEDSLC MBT 022 #44H EUDAMEDM-130-44H-5 EUDAMEDSLC ROTH 018 #13H EUDAMEDM-100-13H-5 EUDAMEDSLC MBT 022 #24H EUDAMEDM-130-24H-5 EUDAMEDSLC MBT 022 #41 EUDAMEDM-130-41-5 EUDAMEDSLC MBT 022 #35H EUDAMEDM-130-35H-5 EUDAMEDSLC ROTH 022 #12 EUDAMEDM-110-12-5 EUDAMEDSLC ROTH 022 #25H EUDAMEDM-110-25H-5 EUDAMEDSLC ROTH 022 #13H EUDAMEDM-110-13H-5 EUDAMEDSLC MBT 022 #42 EUDAMEDM-130-42-5 EUDAMEDSLC ROTH 022 3*3 H3 EUDAMED116-331 EUDAMEDSLC MBT 022 #23H EUDAMEDM-130-23H-5 EUDAMEDSLC ROTH 022 5*3 H345 EUDAMED116-533 EUDAMEDSLC ROTH 018 #11 EUDAMEDM-100-11-5 EUDAMEDSLC ROTH 018 0*3 H3 LOW EUDAMED106-031 EUDAMEDSLC MBT 022 3*3 H3 EUDAMED136-331 EUDAMEDSLC ROTH 022 #15H EUDAMEDM-110-15H-5 EUDAMEDSLC ROTH 022 #41 EUDAMEDM-110-41-5 EUDAMEDSLC MBT 022 #22 EUDAMEDM-130-22-5 EUDAMEDSLC ROTH 022 #34H EUDAMEDM-110-34H-5 EUDAMEDSLC MBT 022 5*0 H345 UP EUDAMED136-503 EUDAMEDSLC ROTH 018 #45H EUDAMEDM-100-45H-5 EUDAMEDSLC ROTH 022 #22 EUDAMEDM-110-22-5 EUDAMEDSLC MBT 022 #32 EUDAMEDM-130-32-5 EUDAMEDSLC MBT 022 3*0 H3 UP EUDAMED136-301 EUDAMEDSLC MBT 022 #21 EUDAMEDM-130-21-5 EUDAMEDSLC ROTH 018 #33H EUDAMEDM-100-33H-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033425991 EUDAMED08800033426479 EUDAMED08800033426356 EUDAMED08800033426585 EUDAMED08800033426110 EUDAMED08800033427339 EUDAMED08800033427414 EUDAMED08800033427674 EUDAMED08800033427094 EUDAMED08800033427131 EUDAMED08800033426196 EUDAMED08800033427636 EUDAMED08800033426936 EUDAMED08800033426431 EUDAMED08800033427872 EUDAMED08800033427919 EUDAMED08800033428237 EUDAMED08800033425878 EUDAMED08800033427834 EUDAMED08800033428114 EUDAMED08800033428077 EUDAMED08800033426691 EUDAMED08800033427018 EUDAMED08800033426738 EUDAMED08800033428152 EUDAMED08800033427469 EUDAMED08800033427797 EUDAMED08800033427452 EUDAMED08800033425793 EUDAMED08800033426639 EUDAMED08800033428329 EUDAMED08800033426813 EUDAMED08800033427254 EUDAMED08800033427759 EUDAMED08800033427179 EUDAMED08800033428336 EUDAMED08800033426554 EUDAMED08800033426899 EUDAMED08800033427957 EUDAMED08800033428343 EUDAMED08800033427711 EUDAMED08800033426271 EUDAMED
- Basic UDI-DI
- B-08800033425991 EUDAMEDB-08800033426479 EUDAMEDB-08800033426356 EUDAMEDB-08800033426585 EUDAMEDB-08800033426110 EUDAMEDB-08800033427339 EUDAMEDB-08800033427414 EUDAMEDB-08800033427674 EUDAMEDB-08800033427094 EUDAMEDB-08800033427131 EUDAMEDB-08800033426196 EUDAMEDB-08800033427636 EUDAMEDB-08800033426936 EUDAMEDB-08800033426431 EUDAMEDB-08800033427872 EUDAMEDB-08800033427919 EUDAMEDB-08800033428237 EUDAMEDB-08800033425878 EUDAMEDB-08800033427834 EUDAMEDB-08800033428114 EUDAMEDB-08800033428077 EUDAMEDB-08800033426691 EUDAMEDB-08800033427018 EUDAMEDB-08800033426738 EUDAMEDB-08800033428152 EUDAMEDB-08800033427469 EUDAMEDB-08800033427797 EUDAMEDB-08800033427452 EUDAMEDB-08800033425793 EUDAMEDB-08800033426639 EUDAMEDB-08800033428329 EUDAMEDB-08800033426813 EUDAMEDB-08800033427254 EUDAMEDB-08800033427759 EUDAMEDB-08800033427179 EUDAMEDB-08800033428336 EUDAMEDB-08800033426554 EUDAMEDB-08800033426899 EUDAMEDB-08800033427957 EUDAMEDB-08800033428343 EUDAMEDB-08800033427711 EUDAMEDB-08800033426271 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDFrance EUDAMEDCroatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthodontic tube
Majesty-Slc by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
- Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800033425991 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osstem Orthodontics Inc.
- EUDAMED SRN
- KR-MF-000021559
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (42)
- EUDAMED 01518115-210a-457d-9b78-9b5ae1a6632b 61 fields · synced Sep 17, 2026
- EUDAMED 01127694-6d23-4340-b803-d6de1d663992 61 fields · synced May 11, 2026
- EUDAMED b04f6815-a470-4a77-a20c-32b601ce7ade 61 fields · synced May 16, 2026
- EUDAMED 3b311d72-fbab-48d4-be52-51172e76ac52 61 fields · synced May 16, 2026
- EUDAMED 1eec8bf0-83fa-47b0-b870-d4b247ce20dd 61 fields · synced May 16, 2026
- EUDAMED bef687ed-4761-43e6-a11e-f52c2de22107 61 fields · synced May 16, 2026
- EUDAMED cf995268-5648-4d93-b7a1-bd8dca82e806 61 fields · synced May 16, 2026
- EUDAMED 3a94449a-46c6-4f32-bbd7-72f2e97a6aa5 61 fields · synced May 16, 2026
- EUDAMED b6402460-9cc8-4f31-8a75-3baeb9f4cab4 61 fields · synced May 16, 2026
- EUDAMED 277ebc43-7a77-4722-a06e-d4ad172b885a 61 fields · synced May 17, 2026
- EUDAMED 3c68bf56-21d7-47c3-a2d1-602dbd54dd50 61 fields · synced May 17, 2026
- EUDAMED 6f792a1b-c38d-4a22-85b9-994e81cc392d 61 fields · synced May 17, 2026
- EUDAMED 3f6dbae8-6b53-42f3-ba3d-c304ced281b9 61 fields · synced May 17, 2026
- EUDAMED 0777c365-c051-4006-aad6-fc9a78f2102d 61 fields · synced May 17, 2026
- EUDAMED de99351d-a2bb-46ad-8ae0-5f5b3bb1c68c 61 fields · synced May 17, 2026
- EUDAMED 0f2abc14-a8a7-47d4-b5cc-169548d2ccd8 61 fields · synced May 17, 2026
- EUDAMED bb7378d9-90ea-4b2d-96f5-c2dfbc92b3c2 61 fields · synced May 17, 2026
- EUDAMED 8b9ddc24-5f83-4589-9edf-ae0be86b8d96 61 fields · synced May 17, 2026
- EUDAMED 08811e47-1b92-447b-93e7-743de69ab458 61 fields · synced May 17, 2026
- EUDAMED 4fba07ca-029d-45d9-aa15-39089f13430c 61 fields · synced May 17, 2026
- EUDAMED 1fa19a86-f77c-40b1-ac29-00467818b88f 61 fields · synced May 17, 2026
- EUDAMED dbf2b386-8403-4037-b350-649a3d27056a 61 fields · synced May 17, 2026
- EUDAMED 228cbcca-ac5c-4994-92d5-e92c7b729b21 61 fields · synced May 18, 2026
- EUDAMED 5d12f129-6a9a-4f29-a6dd-f303613d899b 61 fields · synced May 18, 2026
- EUDAMED 9905aa1f-7ec5-4f37-8d0b-185019715bb9 61 fields · synced May 18, 2026
- EUDAMED 82425a75-0139-400e-8da3-a5cda1afc07c 61 fields · synced May 18, 2026
- EUDAMED bab29825-5e67-4674-b71c-170acca11e45 61 fields · synced May 18, 2026
- EUDAMED cd17c319-49ea-49c1-8ba9-6ea8f116c62e 61 fields · synced May 18, 2026
- EUDAMED 72ae5448-e853-4afb-a4e9-980a7a04f131 61 fields · synced May 18, 2026
- EUDAMED 0919515e-b200-4de3-aa0d-a706f25fb331 61 fields · synced May 18, 2026
- EUDAMED 22980d64-ccbe-479d-8ef8-4e853c34cc41 61 fields · synced May 18, 2026
- EUDAMED 73eabf4f-f961-4c53-96e4-9fb437be5f43 61 fields · synced May 18, 2026
- EUDAMED 2b6e2209-fa66-499a-9cfa-de9b00522743 61 fields · synced May 18, 2026
- EUDAMED 955e473f-4f68-4786-87b1-7816897d5058 61 fields · synced May 18, 2026
- EUDAMED 19edd8f4-8c08-4d73-965f-d9784b1e2382 61 fields · synced May 18, 2026
- EUDAMED 55178070-3614-4d18-9dfe-6ce9b7e9a69f 61 fields · synced May 18, 2026
- EUDAMED 1e1d5cc3-99a3-4619-b91a-473151e782ef 61 fields · synced May 18, 2026
- EUDAMED 60cebd72-1704-4ba1-accc-4446cb488382 61 fields · synced May 18, 2026
- EUDAMED dfd5eb33-60b4-47df-9910-96f0eab19f1b 61 fields · synced May 18, 2026
- EUDAMED 5c5b4240-9771-44dd-8749-a47f64777dbb 61 fields · synced May 19, 2026
- EUDAMED cebd02a7-c4c7-4f77-9fdf-2d7490abe840 61 fields · synced May 19, 2026
- EUDAMED caf7e394-fa4a-43e6-a244-35c9248fce7a 61 fields · synced May 19, 2026