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Outie Tool
EUDAMEDClass I (EU MDR)
Ref 2 in 1 Clear Aligner Invisible Braces Removal Tool | Assorted SinglesModel Version 4.0
Identity
- Trade Name
- Outie Tool EUDAMED
- Device Name
- Outie Tool EUDAMED
- Model / Reference
- Version 4.0 EUDAMED2 in 1 Clear Aligner Invisible Braces Removal Tool | Assorted Singles EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00894365002485 EUDAMED
- Basic UDI-DI
- 894365002OutieTool3Z EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Outie Tool by Nadine & Co., LLC — 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 | 894365002OutieTool3Z | Class I | Active |
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Manufacturer
- Manufacturer
- Nadine & Co., LLC
- EUDAMED SRN
- US-MF-000042485
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 435abcd4-5b93-4097-91e9-e87df07e5e18 61 fields · synced Jun 19, 2026