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Easyclip Opening Tool U
EUDAMEDFDA UDIClass I (EU MDR)
Ref 00.00.0002Model Dental Instruments
Identity
- Trade Name
- EASYCLIP OPENING TOOL U EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic appliance dimension gauge FDA UDI
- Device Name
- Clip Closing Tool FDA UDI
- Model / Reference
- Dental Instruments EUDAMED00.00.0002 EUDAMEDFDA UDI
- Description
- Clip Closing Tool FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439202528 EUDAMEDFDA UDI
- Basic UDI-DI
- 7899439200HS EUDAMED
- FDA Product Code
- ECP FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic appliance dimension gauge FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Easyclip Opening Tool U by Aditek do Brasil SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7899439200HS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aditek do Brasil SA
- EUDAMED SRN
- BR-MF-000018793
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (2)
- EUDAMED 6dc6edd1-efe9-4cd7-b631-310848f6dce0 61 fields · synced Jun 18, 2026
- FDA UDI 3b33a251-71e8-4485-bb1f-06d0357ed721 33 fields · synced May 30, 2026