Identity
- Trade Name
- TopSticks Mini EUDAMED
- Device Name
- Elastomerics EUDAMED
- Model / Reference
- 340-016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810129521559 EUDAMED
- Basic UDI-DI
- 081012952TF01ZM EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
TopSticks Mini by O&S Dental, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 081012952TF01ZM | 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 (1)
- EUDAMED 747a41c3-0d6a-4008-ab61-e01973de0e06 61 fields · synced Aug 4, 2026