Identity
- Trade Name
- TopChain EUDAMED
- Device Name
- Elastomerics EUDAMED
- Model / Reference
- 322-040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810129520859 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
Category: Orthodontic retainer
The TopChain device is a medical device that provides [REPROCESSED: 0] with [MEASURING_FUNCTION: 0] accuracy, making it an ideal solution for [MEDICAL_PURPOSE: 0].
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Also classified as Orthodontic retainer.
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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 | 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 f1534954-b036-4e1e-93d3-a349d4740629 61 fields · synced Jul 18, 2026