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TopChain

EUDAMED

Class I (EU MDR)

Ref 321-004Ref 321-003Ref 321-001Ref 321-014Ref 321-021Ref 323-017Ref 322-007Ref 323-047Ref 322-034Ref 321-017Ref 322-022Ref 323-006Ref 321-048Ref 323-002Ref 322-039Ref 322-013Ref 322-029Ref 323-004Ref 323-045Ref 322-037Ref 322-010Ref 323-016Ref 323-009Ref 321-034Ref 322-008Ref 322-011Ref 323-021Ref 323-040Ref 322-015Ref 323-008Ref 322-030Ref 322-006Ref 322-005Ref 321-040Ref 321-038Ref 322-001Ref 322-043Ref 323-039Ref 321-015Ref 323-038Ref 322-038Ref 323-013Ref 322-014Ref 323-023Ref 321-024Ref 321-029Ref 321-020Ref 321-023Ref 322-017Ref 323-011Ref 322-021Ref 322-012Ref 322-047Ref 323-020Ref 322-048Ref 322-002Ref 322-004Ref 323-048Ref 322-049Ref 321-013Ref 323-041Ref 321-019Ref 322-024Ref 322-025Ref 321-027Ref 323-049Ref 321-025Ref 323-031Ref 322-028Ref 322-023Ref 323-001Ref 322-019Ref 322-016Ref 321-041Ref 321-012Ref 321-035Ref 323-030Ref 321-036Ref 322-026Ref 321-009Ref 323-036

by O&S Dental, Inc.

Identity

Trade Name
TopChain EUDAMED
Device Name
Elastomerics EUDAMED
Model / Reference
321-004 EUDAMED
321-003 EUDAMED
321-001 EUDAMED
321-014 EUDAMED
321-021 EUDAMED
323-017 EUDAMED
322-007 EUDAMED
323-047 EUDAMED
322-034 EUDAMED
321-017 EUDAMED
322-022 EUDAMED
323-006 EUDAMED
321-048 EUDAMED
323-002 EUDAMED
322-039 EUDAMED
322-013 EUDAMED
322-029 EUDAMED
323-004 EUDAMED
323-045 EUDAMED
322-037 EUDAMED
322-010 EUDAMED
323-016 EUDAMED
323-009 EUDAMED
321-034 EUDAMED
322-008 EUDAMED
322-011 EUDAMED
323-021 EUDAMED
323-040 EUDAMED
322-015 EUDAMED
323-008 EUDAMED
322-030 EUDAMED
322-006 EUDAMED
322-005 EUDAMED
321-040 EUDAMED
321-038 EUDAMED
322-001 EUDAMED
322-043 EUDAMED
323-039 EUDAMED
321-015 EUDAMED
323-038 EUDAMED
322-038 EUDAMED
323-013 EUDAMED
322-014 EUDAMED
323-023 EUDAMED
321-024 EUDAMED
321-029 EUDAMED
321-020 EUDAMED
321-023 EUDAMED
322-017 EUDAMED
323-011 EUDAMED
322-021 EUDAMED
322-012 EUDAMED
322-047 EUDAMED
323-020 EUDAMED
322-048 EUDAMED
322-002 EUDAMED
322-004 EUDAMED
323-048 EUDAMED
322-049 EUDAMED
321-013 EUDAMED
323-041 EUDAMED
321-019 EUDAMED
322-024 EUDAMED
322-025 EUDAMED
321-027 EUDAMED
323-049 EUDAMED
321-025 EUDAMED
323-031 EUDAMED
322-028 EUDAMED
322-023 EUDAMED
323-001 EUDAMED
322-019 EUDAMED
322-016 EUDAMED
321-041 EUDAMED
321-012 EUDAMED
321-035 EUDAMED
323-030 EUDAMED
321-036 EUDAMED
322-026 EUDAMED
321-009 EUDAMED
323-036 EUDAMED

Identifiers

Primary DI / UDI-DI
00810129520033 EUDAMED
00810129520026 EUDAMED
00810129520002 EUDAMED
00810129520132 EUDAMED
00810129520200 EUDAMED
00810129521092 EUDAMED
00810129520521 EUDAMED
00810129521368 EUDAMED
00810129520798 EUDAMED
00810129520163 EUDAMED
00810129520675 EUDAMED
00810129520989 EUDAMED
00810129520446 EUDAMED
00810129520941 EUDAMED
00810129520842 EUDAMED
00810129520583 EUDAMED
00810129520743 EUDAMED
00810129520965 EUDAMED
00810129521344 EUDAMED
00810129520828 EUDAMED
00810129520552 EUDAMED
00810129521085 EUDAMED
00810129521016 EUDAMED
00810129520330 EUDAMED
00810129520538 EUDAMED
00810129520569 EUDAMED
00810129521139 EUDAMED
00810129521320 EUDAMED
00810129520606 EUDAMED
00810129521009 EUDAMED
00810129520750 EUDAMED
00810129520514 EUDAMED
00810129520507 EUDAMED
00810129520392 EUDAMED
00810129520378 EUDAMED
00810129520460 EUDAMED
00810129520873 EUDAMED
00810129521313 EUDAMED
00810129520149 EUDAMED
00810129521306 EUDAMED
00810129520835 EUDAMED
00810129521054 EUDAMED
00810129520590 EUDAMED
00810129521153 EUDAMED
00810129520231 EUDAMED
00810129520286 EUDAMED
00810129520194 EUDAMED
00810129520224 EUDAMED
00810129520620 EUDAMED
00810129521030 EUDAMED
00810129520668 EUDAMED
00810129520576 EUDAMED
00810129520903 EUDAMED
00810129521122 EUDAMED
00810129520910 EUDAMED
00810129520477 EUDAMED
00810129520491 EUDAMED
00810129521375 EUDAMED
00810129520927 EUDAMED
00810129520125 EUDAMED
00810129521337 EUDAMED
00810129520187 EUDAMED
00810129520699 EUDAMED
00810129520705 EUDAMED
00810129520262 EUDAMED
00810129521382 EUDAMED
00810129520248 EUDAMED
00810129521238 EUDAMED
00810129520736 EUDAMED
00810129520682 EUDAMED
00810129520934 EUDAMED
00810129520644 EUDAMED
00810129520613 EUDAMED
00810129520408 EUDAMED
00810129520118 EUDAMED
00810129520347 EUDAMED
00810129521221 EUDAMED
00810129520354 EUDAMED
00810129520712 EUDAMED
00810129520088 EUDAMED
00810129521283 EUDAMED
Basic UDI-DI
081744102TF0155 EUDAMED
081012952TF01ZM EUDAMED
EMDN Code
Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Orthodontic retainer

TopChain by O&S Dental, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic retainer.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
O&S Dental, Inc.
EUDAMED SRN
US-MF-000023206
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (81)

  • EUDAMED 60eb10fc-b6ba-4c71-b62d-b1970670526a 61 fields · synced Sep 18, 2026
  • EUDAMED 9f182c64-bc03-463e-8213-e6dc6457ea20 61 fields · synced May 17, 2026
  • EUDAMED 4d827b2d-9c7d-4692-bc3c-322a56d21197 61 fields · synced May 19, 2026
  • EUDAMED f4b869f2-24cc-43c5-9975-e00c6fd8e2c1 61 fields · synced Jun 14, 2026
  • EUDAMED d1dffbcd-66b5-44f7-aa77-933e1fe96ba1 61 fields · synced Jun 20, 2026
  • EUDAMED 7ccdfd50-2469-4988-b694-6c70e2a6b3f6 61 fields · synced Jun 20, 2026
  • EUDAMED c8e7a6d6-ba26-4cfd-b174-a6511380f1a2 61 fields · synced Jul 9, 2026
  • EUDAMED 2bd0449f-d805-4593-a76e-28a510adf703 61 fields · synced Jul 9, 2026
  • EUDAMED 4b62f152-af1f-42b8-824c-be2c3c3fee4f 61 fields · synced Jul 9, 2026
  • EUDAMED 4e90d52a-73a6-40b2-9c18-517f27dd75d5 61 fields · synced Jul 9, 2026
  • EUDAMED 5da70fbc-ef94-40f9-a9cf-7f14239e1bf2 61 fields · synced Jul 9, 2026
  • EUDAMED 39c0217b-2dd0-4817-94f2-88fb8e9599b9 61 fields · synced Jul 10, 2026
  • EUDAMED b0c25528-c2c1-42ca-910c-19a0766a9121 61 fields · synced Jul 10, 2026
  • EUDAMED 3b7308da-6007-4daa-ad30-9d0220f55718 61 fields · synced Jul 10, 2026
  • EUDAMED 85f104b6-290c-4178-9716-2f80eccfde81 61 fields · synced Jul 10, 2026
  • EUDAMED 13970277-81c6-4b5a-8a09-cb389d3f3143 61 fields · synced Jul 10, 2026
  • EUDAMED d81ceaa7-4b01-4046-b473-036cf0ac7956 61 fields · synced Jul 11, 2026
  • EUDAMED c2aef544-9fed-40cd-b502-64164da0a8a0 61 fields · synced Jul 11, 2026
  • EUDAMED 7e1486eb-d990-4648-8b65-8ed5f68c2eea 61 fields · synced Jul 11, 2026
  • EUDAMED 659056f8-a69d-447e-b137-e77cd3b29e19 61 fields · synced Jul 11, 2026
  • EUDAMED 39db08e4-42bb-450a-affe-b0b07640b22c 61 fields · synced Jul 12, 2026
  • EUDAMED 1376fd1f-bd99-4a55-8be3-cd596dbe15cf 61 fields · synced Jul 13, 2026
  • EUDAMED 3f57cd14-bb94-44b0-ada1-d4556fa54ede 61 fields · synced Jul 13, 2026
  • EUDAMED 4048b26c-1868-4694-a82c-f16c8ff3ffeb 61 fields · synced Jul 13, 2026
  • EUDAMED a1347a44-664a-46fe-8921-0bafdba05667 61 fields · synced Jul 13, 2026
  • EUDAMED 1b926f23-70e2-4bb5-99c2-88faaa615e03 61 fields · synced Jul 13, 2026
  • EUDAMED c44b5db3-90a5-41e0-9660-4441ce6353bc 61 fields · synced Jul 13, 2026
  • EUDAMED b60a37be-b35d-4f5c-95de-23e876e0353d 61 fields · synced Jul 14, 2026
  • EUDAMED 35e361ae-de94-49e3-a90d-4ec614673152 61 fields · synced Jul 14, 2026
  • EUDAMED 57004ed4-9769-4d0d-8cb9-9ba9b778ce3e 61 fields · synced Jul 14, 2026
  • EUDAMED 1633a4c3-5fbd-41d5-819e-efe366cc7c7c 61 fields · synced Jul 14, 2026
  • EUDAMED 190d9f01-aae0-40c6-be86-73af0abeb1a3 61 fields · synced Jul 15, 2026
  • EUDAMED 50b2747d-0430-4068-a9c3-6c1850b9e0ac 61 fields · synced Jul 15, 2026
  • EUDAMED 54ebdbc3-3eb2-4098-a3ac-dbde9ac48583 61 fields · synced Jul 15, 2026
  • EUDAMED 26aa3753-5e99-4763-9252-dc9c8f2b9c00 61 fields · synced Jul 15, 2026
  • EUDAMED 8f82ab4a-56d6-4610-a94a-c7107b120b0a 61 fields · synced Jul 15, 2026
  • EUDAMED 81d25a2c-4153-4c89-86b6-b7b3704ec758 61 fields · synced Jul 16, 2026
  • EUDAMED 4ff6a9b9-618d-4a9b-a637-0096eb2d9567 61 fields · synced Jul 16, 2026
  • EUDAMED 9f52402d-1b42-440c-9daf-043832cfbfec 61 fields · synced Jul 16, 2026
  • EUDAMED 53d80098-9e8f-4c8d-a14f-9a500c16b076 61 fields · synced Jul 16, 2026
  • EUDAMED 1614ae16-81cf-42d3-8857-d7e6bd666d26 61 fields · synced Jul 16, 2026
  • EUDAMED 818b5d21-71ae-4e1c-8161-f60b1ef582d7 61 fields · synced Jul 17, 2026
  • EUDAMED 55b29000-b1cf-4b1d-b68d-f2cc9a9b9c89 61 fields · synced Jul 17, 2026
  • EUDAMED 62c39592-463e-4fad-9b5b-46ea5c659e08 61 fields · synced Jul 17, 2026
  • EUDAMED a9779d22-f019-417f-9a22-54398f66b603 61 fields · synced Jul 19, 2026
  • EUDAMED 48660184-6783-44b5-8e25-0cdfbbcbdeaa 61 fields · synced Jul 20, 2026
  • EUDAMED fe845c3c-46df-4b38-b350-13c41bca9a7e 61 fields · synced Jul 20, 2026
  • EUDAMED a8eaa243-2d90-48a2-84eb-8b89fc24550d 61 fields · synced Jul 21, 2026
  • EUDAMED a4ac2b97-4e1f-464c-99dc-6be2d28a165a 61 fields · synced Jul 22, 2026
  • EUDAMED ce828c7e-b8ce-48e8-a2dd-05baca6e1ff4 61 fields · synced Jul 22, 2026
  • EUDAMED 529b0aa5-e993-443d-aee7-1c112a97fe9c 61 fields · synced Jul 22, 2026
  • EUDAMED 9160c4cb-f687-407e-9bca-a3f0b2414bff 61 fields · synced Jul 22, 2026
  • EUDAMED 48b209d7-7ff2-4586-be99-310ea49eb852 61 fields · synced Jul 22, 2026
  • EUDAMED fc8b4648-fe71-4bab-8220-ce0f9c2b848f 61 fields · synced Jul 22, 2026
  • EUDAMED f59a3c7d-7a8e-485f-9b9e-de6708da9f5c 61 fields · synced Jul 23, 2026
  • EUDAMED 5d1e455c-3039-4250-a899-6b0c0d3fc5c7 61 fields · synced Jul 23, 2026
  • EUDAMED e410f57b-405f-431b-ae1c-a80d5f613125 61 fields · synced Jul 23, 2026
  • EUDAMED b34852f3-d620-4b91-9be7-a7dad6fd65cc 61 fields · synced Jul 23, 2026
  • EUDAMED ff9ad6ca-1afe-4b99-b7c0-9a4c049b9cd3 61 fields · synced Jul 24, 2026
  • EUDAMED 13663b2e-7ac6-4d38-a4b8-8849707aaadd 61 fields · synced Jul 25, 2026
  • EUDAMED 48c56087-80e6-4427-9cc1-b0b77143d47d 61 fields · synced Jul 25, 2026
  • EUDAMED c507cdf6-dd57-47e4-b7e5-9f37868fea6a 61 fields · synced Jul 25, 2026
  • EUDAMED a1b43e2a-3937-41b4-90eb-ad23612ed02d 61 fields · synced Jul 26, 2026
  • EUDAMED 5183f81b-70c1-4c40-89de-5fe1502221ba 61 fields · synced Jul 27, 2026
  • EUDAMED 9d5bbb64-4802-4d52-9331-c71246301189 61 fields · synced Jul 27, 2026
  • EUDAMED 76673f73-f5b7-4c45-9a4b-9d2428cff27e 61 fields · synced Jul 28, 2026
  • EUDAMED e4099934-bfae-474a-afa4-7395c4a9f863 61 fields · synced Jul 28, 2026
  • EUDAMED 0b421487-8d9a-431a-b04a-05a2b762f85c 61 fields · synced Jul 29, 2026
  • EUDAMED 3782ddae-8859-43b5-8d5d-7030eb1cf9e5 61 fields · synced Jul 29, 2026
  • EUDAMED 43226669-ac8c-45c5-9818-f46909e9491c 61 fields · synced Jul 30, 2026
  • EUDAMED 5ad2bc88-8077-43d4-b921-443d104b797b 61 fields · synced Jul 30, 2026
  • EUDAMED 41705668-1b76-46da-9276-c676cc9fbbd4 61 fields · synced Jul 31, 2026
  • EUDAMED 6d060255-2b24-4630-95dd-675e2c20d5dd 61 fields · synced Jul 31, 2026
  • EUDAMED e9614d7e-2268-4306-87c9-d3934a6a88a5 61 fields · synced Aug 1, 2026
  • EUDAMED b39dfa0c-2a5d-4a69-ac6e-fc6870551905 61 fields · synced Aug 1, 2026
  • EUDAMED 170ba50f-662f-4d90-bd74-08e5dc18161a 61 fields · synced Aug 2, 2026
  • EUDAMED d46c2852-3a3b-4779-bc7a-62285dbb06fa 61 fields · synced Aug 4, 2026
  • EUDAMED 0151211d-845d-4ec2-b6b6-255ad3a77038 61 fields · synced Aug 4, 2026
  • EUDAMED 5d9dd3fd-3909-435b-88ad-4b5039705ce0 61 fields · synced Aug 4, 2026
  • EUDAMED 6b92ec17-5e81-495a-a156-e2f48a73f4ed 61 fields · synced Sep 17, 2026
  • EUDAMED 55f7dd8a-7a8e-4787-a6e7-8f8d805ebe10 61 fields · synced Sep 18, 2026