Identity
- Trade Name
- Top Sticks EUDAMED
- Device Name
- Elastomerics EUDAMED
- Model / Reference
- 320-003 EUDAMED320-000 EUDAMED320-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850032808033 EUDAMED00850032808002 EUDAMED00850032808019 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
Top Sticks 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 (3)
- EUDAMED 96c78147-af42-4d1c-a668-faf00163769c 61 fields · synced Jul 21, 2026
- EUDAMED e770d7f0-ca07-4135-b8c6-66443d81909a 61 fields · synced May 17, 2026
- EUDAMED 5c9f1216-e951-44f9-8144-0028ed459cd4 61 fields · synced May 18, 2026