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Majesty-Slm
EUDAMEDClass IIa (EU MDR)
Ref 107-031Model 107-031 SLM ROTH 018 0*3 H3Ref 137-35H-5Model SLM MBT 022 #35HRef 107-24H-5Model SLM ROTH 018 #24HRef 137-12-5Model SLM MBT 022 #12Ref 107-331Model 107-331 SLM ROTH 018 3*3 H3Ref 117-45H-5Model SLM ROTH 022 #45HRef 137-31-5Model SLM MBT 022 #31Ref 107-13H-5Model SLM ROTH 018 #13HRef 107-21-5Model SLM ROTH 018 #21Ref 117-35H-5Model SLM ROTH 022 #35HRef 137-24H-5Model SLM MBT 022 #24HRef 117-13H-5Model SLM ROTH 022 #13HRef 137-053Model 137-053 SLM MBT 022 0*5 H345Ref 137-21-5Model SLM MBT 022 #21Ref 137-031Model 137-031 SLM MBT 022 0*3 H3Ref 137-32-5Model SLM MBT 022 #32Ref 137-44H-5Model SLM MBT 022 #44HRef 117-42-5Model SLM ROTH 022 #42Ref 137-22-5Model SLM MBT 022 #22Ref 107-41-5Model SLM ROTH 018 #41Ref 117-34H-5Model SLM ROTH 022 #34HRef 137-13H-5Model SLM MBT 022 #13HRef 107-23H-5Model SLM ROTH 018 #23HRef 107-42-5Model SLM ROTH 018 #42Ref 117-21-5Model SLM ROTH 022 #21Ref 137-553Model 137-553 SLM MBT 022 5*5 H345Ref 107-31-5Model SLM ROTH 018 #31Ref 107-15H-5Model SLM ROTH 018 #15HRef 107-301Model 107-301 SLM ROTH 018 3*0 H3Ref 117-301Model 117-301 SLM ROTH 022 3*0 H3Ref 107-11-5Model SLM ROTH 018 #11Ref 107-12-5Model SLM ROTH 018 #12Ref 107-053Model 107-053 SLM ROTH 018 0*5 H345Ref 117-43H-5Model SLM ROTH 022 #43HRef 137-45H-5Model SLM MBT 022 #45H
Identity
- Trade Name
- MAJESTY-SLM EUDAMED
- Model / Reference
- 107-031 SLM ROTH 018 0*3 H3 EUDAMED107-031 EUDAMEDSLM MBT 022 #35H EUDAMED137-35H-5 EUDAMEDSLM ROTH 018 #24H EUDAMED107-24H-5 EUDAMEDSLM MBT 022 #12 EUDAMED137-12-5 EUDAMED107-331 SLM ROTH 018 3*3 H3 EUDAMED107-331 EUDAMEDSLM ROTH 022 #45H EUDAMED117-45H-5 EUDAMEDSLM MBT 022 #31 EUDAMED137-31-5 EUDAMEDSLM ROTH 018 #13H EUDAMED107-13H-5 EUDAMEDSLM ROTH 018 #21 EUDAMED107-21-5 EUDAMEDSLM ROTH 022 #35H EUDAMED117-35H-5 EUDAMEDSLM MBT 022 #24H EUDAMED137-24H-5 EUDAMEDSLM ROTH 022 #13H EUDAMED117-13H-5 EUDAMED137-053 SLM MBT 022 0*5 H345 EUDAMED137-053 EUDAMEDSLM MBT 022 #21 EUDAMED137-21-5 EUDAMED137-031 SLM MBT 022 0*3 H3 EUDAMED137-031 EUDAMEDSLM MBT 022 #32 EUDAMED137-32-5 EUDAMEDSLM MBT 022 #44H EUDAMED137-44H-5 EUDAMEDSLM ROTH 022 #42 EUDAMED117-42-5 EUDAMEDSLM MBT 022 #22 EUDAMED137-22-5 EUDAMEDSLM ROTH 018 #41 EUDAMED107-41-5 EUDAMEDSLM ROTH 022 #34H EUDAMED117-34H-5 EUDAMEDSLM MBT 022 #13H EUDAMED137-13H-5 EUDAMEDSLM ROTH 018 #23H EUDAMED107-23H-5 EUDAMEDSLM ROTH 018 #42 EUDAMED107-42-5 EUDAMEDSLM ROTH 022 #21 EUDAMED117-21-5 EUDAMED137-553 SLM MBT 022 5*5 H345 EUDAMED137-553 EUDAMEDSLM ROTH 018 #31 EUDAMED107-31-5 EUDAMEDSLM ROTH 018 #15H EUDAMED107-15H-5 EUDAMED107-301 SLM ROTH 018 3*0 H3 EUDAMED107-301 EUDAMED117-301 SLM ROTH 022 3*0 H3 EUDAMED117-301 EUDAMEDSLM ROTH 018 #11 EUDAMED107-11-5 EUDAMEDSLM ROTH 018 #12 EUDAMED107-12-5 EUDAMED107-053 SLM ROTH 018 0*5 H345 EUDAMED107-053 EUDAMEDSLM ROTH 022 #43H EUDAMED117-43H-5 EUDAMEDSLM MBT 022 #45H EUDAMED137-45H-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033431961 EUDAMED08800033431732 EUDAMED08800033429890 EUDAMED08800033431213 EUDAMED08800033431985 EUDAMED08800033431138 EUDAMED08800033431572 EUDAMED08800033429654 EUDAMED08800033429777 EUDAMED08800033430933 EUDAMED08800033431497 EUDAMED08800033430452 EUDAMED08800033432111 EUDAMED08800033431374 EUDAMED08800033432081 EUDAMED08800033431619 EUDAMED08800033431893 EUDAMED08800033431015 EUDAMED08800033431411 EUDAMED08800033430179 EUDAMED08800033430896 EUDAMED08800033431251 EUDAMED08800033429852 EUDAMED08800033430216 EUDAMED08800033430575 EUDAMED08800033432135 EUDAMED08800033429975 EUDAMED08800033429739 EUDAMED08800033431978 EUDAMED08800033432036 EUDAMED08800033429579 EUDAMED08800033429616 EUDAMED08800033431992 EUDAMED08800033431053 EUDAMED08800033431930 EUDAMED
- Basic UDI-DI
- B-08800033431961 EUDAMEDB-08800033431732 EUDAMEDB-08800033429890 EUDAMEDB-08800033431213 EUDAMEDB-08800033431985 EUDAMEDB-08800033431138 EUDAMEDB-08800033431572 EUDAMEDB-08800033429654 EUDAMEDB-08800033429777 EUDAMEDB-08800033430933 EUDAMEDB-08800033431497 EUDAMEDB-08800033430452 EUDAMEDB-08800033432111 EUDAMEDB-08800033431374 EUDAMEDB-08800033432081 EUDAMEDB-08800033431619 EUDAMEDB-08800033431893 EUDAMEDB-08800033431015 EUDAMEDB-08800033431411 EUDAMEDB-08800033430179 EUDAMEDB-08800033430896 EUDAMEDB-08800033431251 EUDAMEDB-08800033429852 EUDAMEDB-08800033430216 EUDAMEDB-08800033430575 EUDAMEDB-08800033432135 EUDAMEDB-08800033429975 EUDAMEDB-08800033429739 EUDAMEDB-08800033431978 EUDAMEDB-08800033432036 EUDAMEDB-08800033429579 EUDAMEDB-08800033429616 EUDAMEDB-08800033431992 EUDAMEDB-08800033431053 EUDAMEDB-08800033431930 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDFrance EUDAMEDHungary 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-Slm by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic tube.
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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-08800033431961 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Osstem Orthodontics Inc.
- EUDAMED SRN
- KR-MF-000021559
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (35)
- EUDAMED 737c9ff3-d953-489c-85e6-89615d3a42c1 61 fields · synced Sep 18, 2026
- EUDAMED cf74fa4b-69b3-49a5-bcad-87ed4cb86a44 61 fields · synced May 11, 2026
- EUDAMED 820aa891-168d-4808-b50c-febdcf8f2911 61 fields · synced May 16, 2026
- EUDAMED 73a65792-1763-4676-b414-d8258951507a 61 fields · synced May 16, 2026
- EUDAMED 93300dd7-d939-4e3c-8dc8-9469f675838f 61 fields · synced May 16, 2026
- EUDAMED c15de27c-5c7e-400c-9bb4-dedd0dda4c06 61 fields · synced May 17, 2026
- EUDAMED e89f69d5-7a35-4185-b41d-600305ac61fe 61 fields · synced May 17, 2026
- EUDAMED 9f881d8e-8269-4e4e-ad68-255f83c2911f 61 fields · synced May 17, 2026
- EUDAMED 18783879-45a8-4ae1-afd7-5287748c061f 61 fields · synced May 17, 2026
- EUDAMED d50e32a2-e441-40fe-b5a6-30c4f1a09b59 61 fields · synced May 17, 2026
- EUDAMED 66f4a782-369a-4efd-9796-35202af6ff91 61 fields · synced May 17, 2026
- EUDAMED 9bf9bce0-29e4-4188-a626-a08cb1f63b43 61 fields · synced May 17, 2026
- EUDAMED fedd1d09-13cb-4752-9b73-8be5ba5be0ce 61 fields · synced May 17, 2026
- EUDAMED a193e307-cab3-4a8b-a97e-13deecba8fad 61 fields · synced May 17, 2026
- EUDAMED 2444fbaf-dcea-4840-bbca-e63726bf9b23 61 fields · synced May 17, 2026
- EUDAMED 92758d9f-c4db-4b5c-8f6c-65e195dd0146 61 fields · synced May 17, 2026
- EUDAMED ade1333e-f9c9-4726-a4ca-75bef56d83bb 61 fields · synced May 17, 2026
- EUDAMED 9580b6fd-e45f-4519-9233-ee5a432b281e 61 fields · synced May 17, 2026
- EUDAMED d040a18b-eba2-440e-8802-060beb23e8f2 61 fields · synced May 17, 2026
- EUDAMED ab4022ee-aee3-4d43-83cd-84109b014396 61 fields · synced May 17, 2026
- EUDAMED 948a2e68-4de0-41ef-b01b-4f166d6942fa 61 fields · synced May 18, 2026
- EUDAMED 4406a452-77d2-4ec8-93bd-0d22b0f170c5 61 fields · synced May 18, 2026
- EUDAMED e3197f79-ea06-452c-bc92-3cedec4160a4 61 fields · synced May 18, 2026
- EUDAMED 1530fd8a-eec1-4d71-9699-9b9058638510 61 fields · synced May 18, 2026
- EUDAMED 57eb2448-c024-4863-b058-baa79860ce8f 61 fields · synced May 18, 2026
- EUDAMED bc11ca3e-41e1-4daf-8628-a33cef75d51d 61 fields · synced May 18, 2026
- EUDAMED d30dc96a-3003-4a5c-9620-772bec4a6053 61 fields · synced May 18, 2026
- EUDAMED 916e22c5-d37d-4230-9651-e0c3f257d58e 61 fields · synced May 18, 2026
- EUDAMED a18f4aa7-4956-473c-ba65-ceaa6a838961 61 fields · synced May 18, 2026
- EUDAMED 933c6712-7d3f-4e21-a310-7dedae30ddae 61 fields · synced May 18, 2026
- EUDAMED d1343d96-783e-4ad8-9ea8-44c56f03c314 61 fields · synced May 18, 2026
- EUDAMED 7b5c0a9e-93c5-43e0-a409-272d71e2a19b 61 fields · synced May 18, 2026
- EUDAMED 1ae5b9ff-723e-43d7-8419-43de7db49738 61 fields · synced May 19, 2026
- EUDAMED 2a4daa79-5fe8-462a-a4eb-97231c706dfc 61 fields · synced May 19, 2026
- EUDAMED 6d956769-7196-41bd-8236-3615723c71c7 61 fields · synced May 19, 2026