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Ss Archwire Natural Upper 018x025 W/100
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 09.05.0585.0Model Archwires and WiresRef 09.05.0575.0IRef 09.05.0595.0Ref 09.05.0595.0IRef 09.05.0585.0I
Identity
- Trade Name
- SS ARCHWIRE NATURAL UPPER 018X025 W/100 EUDAMEDSS ARCHWIRE NATURAL UPPER 017X025 INDIVIDUAL W/100 EUDAMEDSS ARCHWIRE NATURAL UPPER 019X025 W/100 EUDAMEDSS Archwire Natural Upper 019X025 Individual w/100 EUDAMEDSS Archwire Natural Upper 018X025 Individual w/100 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- SS Archwire Natural Upper 019X025 w/100 EUDAMEDFDA UDISS Archwire Natural Upper 019X025 Individual w/100 EUDAMEDFDA UDISS Archwire Natural Upper 018X025 Individual w/100 EUDAMEDFDA UDISS Archwire Natural Upper 017X025 Individual w/100 FDA UDI
- Model / Reference
- Archwires and Wires EUDAMED09.05.0585.0 EUDAMED09.05.0575.0I EUDAMEDFDA UDI09.05.0595.0 EUDAMEDFDA UDI09.05.0595.0I EUDAMEDFDA UDI09.05.0585.0I EUDAMEDFDA UDI
- Description
- SS Archwire Natural Upper 019X025 w/100 FDA UDISS Archwire Natural Upper 019X025 Individual w/100 FDA UDISS Archwire Natural Upper 018X025 Individual w/100 FDA UDISS Archwire Natural Upper 017X025 Individual w/100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439276826 EUDAMEDFDA UDI07899439276345 EUDAMEDFDA UDI07899439277755 EUDAMEDFDA UDI07899439234352 EUDAMEDFDA UDI
- Basic UDI-DI
- 7899439209JC EUDAMEDB-07899439234352 EUDAMEDB-07899439277755 EUDAMEDB-07899439276826 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic wire FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Ss Archwire Natural Upper 018x025 W/100 by Aditek do Brasil SA — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7899439209JC | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7899439209JC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (11)
- EUDAMED 352eaac6-5a38-49c8-8fb9-78300957a16a 61 fields · synced Aug 1, 2026
- EUDAMED 3e3a10e5-ed98-4199-897a-3704e1875635 61 fields · synced May 18, 2026
- EUDAMED daac553c-87e6-4baf-8188-faf9723df77b 61 fields · synced May 18, 2026
- EUDAMED 3504161f-bad6-4c85-ac42-17a17d79c14b 61 fields · synced May 19, 2026
- FDA UDI e7692bd6-0167-4b70-9185-41f9127b5d0b 33 fields · synced May 29, 2026
- FDA UDI d61f14f6-ee17-4a00-a19d-f24fe66c10e7 33 fields · synced May 30, 2026
- FDA UDI a5b7aa96-d48f-44e3-8518-09299c7e3750 33 fields · synced May 30, 2026
- FDA UDI d37af952-f4e4-4e08-817b-9119f869825f 33 fields · synced May 30, 2026
- EUDAMED dd70721c-3222-4d24-b578-084c01dafd5b 61 fields · synced Jul 10, 2026
- EUDAMED 1ec1cd79-a8b3-4fa0-afcc-fcf2c653121f 61 fields · synced Jul 29, 2026
- EUDAMED b427ac5b-5d18-43dd-817f-bb1e2b38d05b 61 fields · synced Aug 1, 2026