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TopSticks
EUDAMEDClass I (EU MDR)
Ref 320-036Ref 320-035Ref 320-005Ref 320-048Ref 320-037Ref 320-038Ref 320-028Ref 320-007Ref 320-008Ref 320-010Ref 320-040Ref 320-025Ref 320-015Ref 320-047Ref 320-044Ref 320-031Ref 320-024Ref 320-030Ref 320-009Ref 320-049Ref 320-045Ref 320-021Ref 320-016Ref 320-026
Identity
- Trade Name
- TopSticks EUDAMED
- Device Name
- Elastomerics EUDAMED
- Model / Reference
- 320-036 EUDAMED320-035 EUDAMED320-005 EUDAMED320-048 EUDAMED320-037 EUDAMED320-038 EUDAMED320-028 EUDAMED320-007 EUDAMED320-008 EUDAMED320-010 EUDAMED320-040 EUDAMED320-025 EUDAMED320-015 EUDAMED320-047 EUDAMED320-044 EUDAMED320-031 EUDAMED320-024 EUDAMED320-030 EUDAMED320-009 EUDAMED320-049 EUDAMED320-045 EUDAMED320-021 EUDAMED320-016 EUDAMED320-026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850032808361 EUDAMED00850032808354 EUDAMED00850032808057 EUDAMED00850032808484 EUDAMED00850032808378 EUDAMED00850032808385 EUDAMED00850032808286 EUDAMED00850032808071 EUDAMED00850032808088 EUDAMED00850032808101 EUDAMED00850032808408 EUDAMED00850032808255 EUDAMED00850032808156 EUDAMED00850032808477 EUDAMED00850032808446 EUDAMED00850032808316 EUDAMED00850032808248 EUDAMED00850032808309 EUDAMED00850032808095 EUDAMED00850032808491 EUDAMED00850032808453 EUDAMED00850032808217 EUDAMED00850032808163 EUDAMED00850032808262 EUDAMED
- Basic UDI-DI
- 081744102TF0155 EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
TopSticks by O&S Dental, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081744102TF0155 | Class I | Active |
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Manufacturer
- Manufacturer
- O&S Dental, Inc.
- EUDAMED SRN
- US-MF-000023206
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (24)
- EUDAMED 0cb1f79c-6fa6-46c6-a4f2-dbbdbe21f994 61 fields · synced Aug 4, 2026
- EUDAMED bf055839-4a71-4234-8c81-328bd1d64a74 61 fields · synced May 11, 2026
- EUDAMED ceb15194-695d-4db6-b011-f451e7e86537 61 fields · synced May 11, 2026
- EUDAMED 2438907b-b3a8-4778-83ee-f40864ecf3f0 61 fields · synced May 16, 2026
- EUDAMED df1e4217-0b61-4c7f-8866-61d2a4e540a9 61 fields · synced May 16, 2026
- EUDAMED 6b6862b5-1cde-4c9b-9726-7cfa996b43b1 61 fields · synced May 16, 2026
- EUDAMED db8d16ef-8607-479d-abbd-03179ff248fa 61 fields · synced May 16, 2026
- EUDAMED 0767c37a-677e-4bcc-af85-cc08712ec052 61 fields · synced May 16, 2026
- EUDAMED c276fdd7-96cb-4423-83f3-d8ad2e3f309b 61 fields · synced May 17, 2026
- EUDAMED 0fa416c9-9dff-4e09-a325-f639b685d098 61 fields · synced May 17, 2026
- EUDAMED 641cb0e8-47a7-4c08-9b51-f4c53ec7d825 61 fields · synced May 17, 2026
- EUDAMED e37a35f5-0e8a-4963-b9d7-d6fc874f121f 61 fields · synced May 17, 2026
- EUDAMED 4f9ffcbf-85c4-48db-ae2e-ee420372933c 61 fields · synced May 18, 2026
- EUDAMED 0517b26c-181f-4cc3-859a-003f650d6055 61 fields · synced May 18, 2026
- EUDAMED 46871c93-bedb-4c97-9bf8-f70d1e9f5748 61 fields · synced May 18, 2026
- EUDAMED fafa29e4-101f-4e1a-9837-dd0cbebad219 61 fields · synced May 18, 2026
- EUDAMED 5da041e0-a17c-4739-ac64-0b8b09f7f448 61 fields · synced May 18, 2026
- EUDAMED 5fa1ca77-cd6d-4dda-854c-bdefe307f21b 61 fields · synced May 18, 2026
- EUDAMED d274b595-6deb-4371-8d82-867e91016bc5 61 fields · synced May 18, 2026
- EUDAMED b439f351-9d7e-4bce-a90c-4e2a101cd941 61 fields · synced May 18, 2026
- EUDAMED 940646ba-ed27-4388-a9b5-085dcfaf2068 61 fields · synced May 19, 2026
- EUDAMED a33d4a43-582c-4223-a6b3-963309f01f1c 61 fields · synced May 19, 2026
- EUDAMED 9c06cf49-b6a7-42fb-8474-b48369f1e901 61 fields · synced May 19, 2026
- EUDAMED 32fc14d4-b9ec-46b7-82dd-33f2677403a7 61 fields · synced May 19, 2026