Ss Archwire Natural Lower 018x025 W/10
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- SS ARCHWIRE NATURAL LOWER 018X025 W/10 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- SS Archwire Natural Lower 018X025 w/10 EUDAMEDFDA UDI
- Model / Reference
- Archwires and Wires EUDAMED09.05.0685 EUDAMEDFDA UDI
- Description
- SS Archwire Natural Lower 018X025 w/10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439260863 EUDAMEDFDA UDI
- Basic UDI-DI
- 7899439209JC EUDAMEDB-07899439260863 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
This SS ARCHWIRE NATURAL LOWER 018X025 W/10 device is a medical product used for the treatment of certain medical conditions. It is designed to be implanted in the body and provides a sterile environment for sensitive procedures. The device has undergone rigorous testing and meets the necessary standards for its intended use.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
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 (3)
- EUDAMED 5f939ebe-3016-4625-b4b9-0727f4ad2ec6 61 fields · synced Jul 26, 2026
- FDA UDI d5a0ab40-0da4-4355-b573-6f02cf7bfdf5 33 fields · synced May 30, 2026
- EUDAMED 78849c90-e5bf-4140-811d-d71c78c3458f 61 fields · synced Jun 11, 2026