Sm Tube

EUDAMED

Class IIa (EU MDR)

Ref 501-27-10Model SM TUBE ROTH 018 WELDABLE #27Ref 510-26-10Model SM TUBE ROTH 022 #26Ref 531-47-10Model SM TUBE MBT 022 WELDABLE #47Ref 565-47-10Model SM TUBE 018 Type2 #47Ref 570-47-10Model SM TUBE 022 Type1 #47Ref 565-37-10Model SM TUBE 018 Type2 #37Ref 503-16-10Model TWIN TUBE ROTH 018 WELDABLE #16Ref 510-37-10Model SM TUBE ROTH 022 #37Ref 530-020Model SM_Single_Bon_M-022 0*2 LRef 531-46-10Model SM TUBE MBT 022 WELDABLE #46Ref 540-16-10Model STD TUBE ROTH 018 #16Ref 511-36-10Model SM TUBE ROTH 022 WELDABLE #36Ref 531-26-10Model SM TUBE MBT 022 WELDABLE #26Ref 532-26-10Model TWIN TUBE MBT 022 #26Ref 500-200Model SM_Single_Bon_R-018 2*0 URef 590-47-10Model SM TUBE 022 Type3 #47Ref 590-17-10Model SM TUBE 022 Type3 #17Ref 531-27-10Model SM TUBE MBT 022 WELDABLE #27Ref 530-27-10Model SM TUBE MBT 022 #27Ref 502-16-10Model TWIN TUBE ROTH 018 #16Ref 531-17-10Model SM TUBE MBT 022 WELDABLE #17Ref 560-27-10Model SM TUBE 018 Type1 #27Ref 590-37-10Model SM TUBE 022 Type3 #37Ref 560-17-10Model SM TUBE 018 Type1 #17Ref 570-27-10Model SM TUBE 022 Type1 #27Ref 510-16-10Model SM TUBE ROTH 022 #16Ref 500-46-10Model SM TUBE ROTH 018 #46Ref 532-46-10Model TWIN TUBE MBT 022 #46Ref 501-46-10Model SM TUBE ROTH 018 WELDABLE #46Ref 501-26-10Model SM TUBE ROTH 018 WELDABLE #26Ref 501-16-10Model SM TUBE ROTH 018 WELDABLE #16Ref 512-36-10Model TWIN TUBE ROTH 022 #36Ref 500-47-10Model SM TUBE ROTH 018 #47Ref 511-37-10Model SM TUBE ROTH 022 WELDABLE #37Ref 550-16-10Model STD TUBE ROTH 022 #16Ref 575-27-10Model SM TUBE 022 Type2 #27Ref 531-36-10Model SM TUBE MBT 022 WELDABLE #36Ref 500-37-10Model SM TUBE ROTH 018 #37Ref 530-26-10Model SM TUBE MBT 022 #26Ref 530-37-10Model SM TUBE MBT 022 #37Ref 502-26-10Model TWIN TUBE ROTH 018 #26Ref 510-17-10Model SM TUBE ROTH 022 #17Ref 501-17-10Model SM TUBE ROTH 018 WELDABLE #17Ref 503-36-10Model TWIN TUBE ROTH 018 WELDABLE #36Ref 500-26-10Model SM TUBE ROTH 018 #26Ref 511-26-10Model SM TUBE ROTH 022 WELDABLE #26Ref 503-26-10Model TWIN TUBE ROTH 018 WELDABLE #26Ref 530-200Model SM_Single_Bon_M-022 2*0 URef 511-27-10Model SM TUBE ROTH 022 WELDABLE #27Ref 565-27-10Model SM TUBE 018 Type2 #27Ref 501-36-10Model SM TUBE ROTH 018 WELDABLE #36Ref 575-47-10Model SM TUBE 022 Type2 #47

by Osstem Orthodontics Inc.

Identity

Trade Name: SM TUBE EUDAMED
Model / Reference: SM TUBE ROTH 018 WELDABLE #27 EUDAMED
501-27-10 EUDAMED
SM TUBE ROTH 022 #26 EUDAMED
510-26-10 EUDAMED
SM TUBE MBT 022 WELDABLE #47 EUDAMED
531-47-10 EUDAMED
SM TUBE 018 Type2 #47 EUDAMED
565-47-10 EUDAMED
SM TUBE 022 Type1 #47 EUDAMED
570-47-10 EUDAMED
SM TUBE 018 Type2 #37 EUDAMED
565-37-10 EUDAMED
TWIN TUBE ROTH 018 WELDABLE #16 EUDAMED
503-16-10 EUDAMED
SM TUBE ROTH 022 #37 EUDAMED
510-37-10 EUDAMED
SM_Single_Bon_M-022 0*2 L EUDAMED
530-020 EUDAMED
SM TUBE MBT 022 WELDABLE #46 EUDAMED
531-46-10 EUDAMED
STD TUBE ROTH 018 #16 EUDAMED
540-16-10 EUDAMED
SM TUBE ROTH 022 WELDABLE #36 EUDAMED
511-36-10 EUDAMED
SM TUBE MBT 022 WELDABLE #26 EUDAMED
531-26-10 EUDAMED
TWIN TUBE MBT 022 #26 EUDAMED
532-26-10 EUDAMED
SM_Single_Bon_R-018 2*0 U EUDAMED
500-200 EUDAMED
SM TUBE 022 Type3 #47 EUDAMED
590-47-10 EUDAMED
SM TUBE 022 Type3 #17 EUDAMED
590-17-10 EUDAMED
SM TUBE MBT 022 WELDABLE #27 EUDAMED
531-27-10 EUDAMED
SM TUBE MBT 022 #27 EUDAMED
530-27-10 EUDAMED
TWIN TUBE ROTH 018 #16 EUDAMED
502-16-10 EUDAMED
SM TUBE MBT 022 WELDABLE #17 EUDAMED
531-17-10 EUDAMED
SM TUBE 018 Type1 #27 EUDAMED
560-27-10 EUDAMED
SM TUBE 022 Type3 #37 EUDAMED
590-37-10 EUDAMED
SM TUBE 018 Type1 #17 EUDAMED
560-17-10 EUDAMED
SM TUBE 022 Type1 #27 EUDAMED
570-27-10 EUDAMED
SM TUBE ROTH 022 #16 EUDAMED
510-16-10 EUDAMED
SM TUBE ROTH 018 #46 EUDAMED
500-46-10 EUDAMED
TWIN TUBE MBT 022 #46 EUDAMED
532-46-10 EUDAMED
SM TUBE ROTH 018 WELDABLE #46 EUDAMED
501-46-10 EUDAMED
SM TUBE ROTH 018 WELDABLE #26 EUDAMED
501-26-10 EUDAMED
SM TUBE ROTH 018 WELDABLE #16 EUDAMED
501-16-10 EUDAMED
TWIN TUBE ROTH 022 #36 EUDAMED
512-36-10 EUDAMED
SM TUBE ROTH 018 #47 EUDAMED
500-47-10 EUDAMED
SM TUBE ROTH 022 WELDABLE #37 EUDAMED
511-37-10 EUDAMED
STD TUBE ROTH 022 #16 EUDAMED
550-16-10 EUDAMED
SM TUBE 022 Type2 #27 EUDAMED
575-27-10 EUDAMED
SM TUBE MBT 022 WELDABLE #36 EUDAMED
531-36-10 EUDAMED
SM TUBE ROTH 018 #37 EUDAMED
500-37-10 EUDAMED
SM TUBE MBT 022 #26 EUDAMED
530-26-10 EUDAMED
SM TUBE MBT 022 #37 EUDAMED
530-37-10 EUDAMED
TWIN TUBE ROTH 018 #26 EUDAMED
502-26-10 EUDAMED
SM TUBE ROTH 022 #17 EUDAMED
510-17-10 EUDAMED
SM TUBE ROTH 018 WELDABLE #17 EUDAMED
501-17-10 EUDAMED
TWIN TUBE ROTH 018 WELDABLE #36 EUDAMED
503-36-10 EUDAMED
SM TUBE ROTH 018 #26 EUDAMED
500-26-10 EUDAMED
SM TUBE ROTH 022 WELDABLE #26 EUDAMED
511-26-10 EUDAMED
TWIN TUBE ROTH 018 WELDABLE #26 EUDAMED
503-26-10 EUDAMED
SM_Single_Bon_M-022 2*0 U EUDAMED
530-200 EUDAMED
SM TUBE ROTH 022 WELDABLE #27 EUDAMED
511-27-10 EUDAMED
SM TUBE 018 Type2 #27 EUDAMED
565-27-10 EUDAMED
SM TUBE ROTH 018 WELDABLE #36 EUDAMED
501-36-10 EUDAMED
SM TUBE 022 Type2 #47 EUDAMED
575-47-10 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800033433521 EUDAMED
08800033432647 EUDAMED
08800033433880 EUDAMED
08800033432609 EUDAMED
08800033432845 EUDAMED
08800033432586 EUDAMED
08800033433989 EUDAMED
08800033432746 EUDAMED
08800033434740 EUDAMED
08800033433804 EUDAMED
08800033433941 EUDAMED
08800033433620 EUDAMED
08800033433767 EUDAMED
08800033433361 EUDAMED
08800033434696 EUDAMED
08800033433163 EUDAMED
08800033433101 EUDAMED
08800033433842 EUDAMED
08800033433040 EUDAMED
08800033433187 EUDAMED
08800033433828 EUDAMED
08800033432487 EUDAMED
08800033433149 EUDAMED
08800033432463 EUDAMED
08800033432807 EUDAMED
08800033432623 EUDAMED
08800033432364 EUDAMED
08800033433408 EUDAMED
08800033433484 EUDAMED
08800033433446 EUDAMED
08800033433422 EUDAMED
08800033433309 EUDAMED
08800033432449 EUDAMED
08800033433705 EUDAMED
08800033433903 EUDAMED
08800033432883 EUDAMED
08800033433781 EUDAMED
08800033432425 EUDAMED
08800033432968 EUDAMED
08800033433064 EUDAMED
08800033433200 EUDAMED
08800033432708 EUDAMED
08800033433507 EUDAMED
08800033434023 EUDAMED
08800033432326 EUDAMED
08800033433606 EUDAMED
08800033434009 EUDAMED
08800033434733 EUDAMED
08800033433682 EUDAMED
08800033432562 EUDAMED
08800033433460 EUDAMED
08800033432920 EUDAMED
Basic UDI-DI: B-08800033433521 EUDAMED
B-08800033432647 EUDAMED
B-08800033433880 EUDAMED
B-08800033432609 EUDAMED
B-08800033432845 EUDAMED
B-08800033432586 EUDAMED
B-08800033433989 EUDAMED
B-08800033432746 EUDAMED
B-08800033434740 EUDAMED
B-08800033433804 EUDAMED
B-08800033433941 EUDAMED
B-08800033433620 EUDAMED
B-08800033433767 EUDAMED
B-08800033433361 EUDAMED
B-08800033434696 EUDAMED
B-08800033433163 EUDAMED
B-08800033433101 EUDAMED
B-08800033433842 EUDAMED
B-08800033433040 EUDAMED
B-08800033433187 EUDAMED
B-08800033433828 EUDAMED
B-08800033432487 EUDAMED
B-08800033433149 EUDAMED
B-08800033432463 EUDAMED
B-08800033432807 EUDAMED
B-08800033432623 EUDAMED
B-08800033432364 EUDAMED
B-08800033433408 EUDAMED
B-08800033433484 EUDAMED
B-08800033433446 EUDAMED
B-08800033433422 EUDAMED
B-08800033433309 EUDAMED
B-08800033432449 EUDAMED
B-08800033433705 EUDAMED
B-08800033433903 EUDAMED
B-08800033432883 EUDAMED
B-08800033433781 EUDAMED
B-08800033432425 EUDAMED
B-08800033432968 EUDAMED
B-08800033433064 EUDAMED
B-08800033433200 EUDAMED
B-08800033432708 EUDAMED
B-08800033433507 EUDAMED
B-08800033434023 EUDAMED
B-08800033432326 EUDAMED
B-08800033433606 EUDAMED
B-08800033434009 EUDAMED
B-08800033434733 EUDAMED
B-08800033433682 EUDAMED
B-08800033432562 EUDAMED
B-08800033433460 EUDAMED
B-08800033432920 EUDAMED
EMDN Code: Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Hungary EUDAMED
Romania EUDAMED
Luxembourg EUDAMED
Italy EUDAMED
Poland EUDAMED
Croatia EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Orthodontic tube

Sm Tube 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-08800033433521	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 (52)

EUDAMED 3f7c6ea9-b987-4633-b2eb-67031971e2e6 61 fields · synced Sep 17, 2026
EUDAMED c352e680-5483-45a7-ba8a-36d0f90e7e91 61 fields · synced May 16, 2026
EUDAMED 449ea86e-48af-4a84-8a3a-4822e4db01ea 61 fields · synced May 16, 2026
EUDAMED fa17649b-34d6-4634-811d-cfe156c7594a 61 fields · synced May 16, 2026
EUDAMED baa6e6fb-83fe-4f0d-81c9-e68a656dba21 61 fields · synced May 16, 2026
EUDAMED 82242b90-ae3f-43ba-a630-890e73a749c1 61 fields · synced May 16, 2026
EUDAMED 9d4bbe09-514d-41d5-ba2c-5af415547495 61 fields · synced May 16, 2026
EUDAMED c52ae1b9-9ea2-4d54-aaf4-2ab5257ccafa 61 fields · synced May 16, 2026
EUDAMED af5ed88c-3378-461f-a7e2-aeebb0c60274 61 fields · synced May 16, 2026
EUDAMED 3aae0d92-5d0a-48d6-865e-6f95536cb1ad 61 fields · synced May 16, 2026
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EUDAMED 44dfc9b4-443e-409a-82af-744383e8aa6a 61 fields · synced May 16, 2026
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EUDAMED fb6f69a4-758d-4022-aa07-fc542f22b943 61 fields · synced May 17, 2026
EUDAMED c3f2e75c-f94d-4c21-8f5a-b229a1dfb3b2 61 fields · synced May 17, 2026
EUDAMED 7ff45c27-9f93-4e0a-aa87-7f45cdef4b6f 61 fields · synced May 17, 2026
EUDAMED 21590af8-eb1d-4e9b-99a0-ebed88d958cb 61 fields · synced May 17, 2026
EUDAMED d59e7f35-bff4-4056-808b-ac9b8ead99d0 61 fields · synced May 17, 2026
EUDAMED 1519b570-0f38-4a9c-a920-12adffaf9903 61 fields · synced May 17, 2026
EUDAMED a19c9865-027d-487a-979a-042b622d7fb8 61 fields · synced May 17, 2026
EUDAMED dfaefe0f-a769-4751-923c-104701c983f3 61 fields · synced May 17, 2026
EUDAMED ea4f74c8-2364-4973-8d50-803f8c9aa2b9 61 fields · synced May 17, 2026
EUDAMED 06c55605-585a-4215-ab97-1a3feb75ad41 61 fields · synced May 17, 2026
EUDAMED 7ce5f313-0fb2-49aa-a79f-6da01b12b386 61 fields · synced May 17, 2026
EUDAMED defea81f-071e-45ee-9cb8-7e88f679b061 61 fields · synced May 17, 2026
EUDAMED d62e50ca-0269-436b-a676-63860a2b8db8 61 fields · synced May 17, 2026
EUDAMED c26e4cb3-c08a-4de5-b6a3-5f4cc6fd060e 61 fields · synced May 18, 2026
EUDAMED 9d841931-e246-4777-82bc-a6802592caff 61 fields · synced May 18, 2026
EUDAMED 1444d079-d189-4cc8-b38b-2472cffd31f8 61 fields · synced May 18, 2026
EUDAMED 8f04e0dd-9151-422a-b804-a064fc3979d2 61 fields · synced May 18, 2026
EUDAMED 04baa7ed-949d-462a-b9f8-9236e5619e3f 61 fields · synced May 18, 2026
EUDAMED 3c801603-0ecf-4e1b-92bc-496dfed73426 61 fields · synced May 18, 2026
EUDAMED f9a36ad0-071d-4bb8-9d8c-5ec1dfdc838b 61 fields · synced May 18, 2026
EUDAMED dc06ce9d-48e9-4323-aadf-43520128b090 61 fields · synced May 18, 2026
EUDAMED d68be87d-77d5-4a5d-bebe-ea12afabddcc 61 fields · synced May 18, 2026
EUDAMED 49f14885-7b6a-4e8c-b447-98a3523da751 61 fields · synced May 18, 2026
EUDAMED 1214d664-f7c5-469b-9885-1cb6a8c2aa83 61 fields · synced May 18, 2026
EUDAMED ae68039f-7764-4e06-8547-095dedc05984 61 fields · synced May 18, 2026
EUDAMED fdb49bb7-8722-440c-afb2-9c91c8e195ab 61 fields · synced May 19, 2026
EUDAMED a3a6f72a-d5bd-4688-aa43-47266e6a3509 61 fields · synced May 19, 2026
EUDAMED 213eb48b-fe8a-4ce9-a337-0dd43d358453 61 fields · synced May 19, 2026
EUDAMED ac39fa84-afcf-42f4-8dd0-c44fd351bb9f 61 fields · synced May 19, 2026
EUDAMED d8d04aae-69d5-4356-9559-96d1fc09dae9 61 fields · synced May 19, 2026
EUDAMED 3dceef23-389b-46b4-889b-bfd521909291 61 fields · synced May 19, 2026
EUDAMED 663115cf-1313-4471-b993-cd97d1eef289 61 fields · synced May 19, 2026
EUDAMED 9e0c3f6b-0e86-4c06-a117-c6fe04dbfd6f 61 fields · synced May 19, 2026