← Back to catalogue
Outie Tool
EUDAMEDClass I (EU MDR)
Ref Singles Pacific Outie ToolModel Version 4.0
Identity
- Trade Name
- Outie Tool EUDAMED
- Device Name
- Outie Tool EUDAMED
- Model / Reference
- Version 4.0 EUDAMEDSingles Pacific Outie Tool EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00894365002119 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nadine & Co., LLC
- EUDAMED SRN
- US-MF-000042485
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 46216532-09cb-4fad-86a2-1fcaafa8f5f7 61 fields · synced Jun 19, 2026