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Outie Tool
EUDAMEDClass I (EU MDR)
Ref Sky Blue SinglesModel Version 4.0Ref MidnightRef Hot PinkRef Neon Green Singles
Identity
- Trade Name
- Outie Tool EUDAMED
- Device Name
- Outie Tool EUDAMED
- Model / Reference
- Version 4.0 EUDAMEDSky Blue Singles EUDAMEDMidnight EUDAMEDHot Pink EUDAMEDNeon Green Singles EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00894365002768 EUDAMED00860004689324 EUDAMED00894365002270 EUDAMED00860004689317 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 (4)
- EUDAMED f5c25f8b-ef70-4332-afd7-baaa550a53b7 61 fields · synced Aug 2, 2026
- EUDAMED e2f14e9b-d368-4b6d-b399-6674c1cbad44 61 fields · synced May 17, 2026
- EUDAMED f8626908-8a2d-44d0-b5f5-4d288e3d0013 61 fields · synced May 17, 2026
- EUDAMED e4dd3003-4b5a-4b2f-88b1-64c0aee7ce3d 61 fields · synced May 18, 2026