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Titanmagnetics
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref P.62.01.Y100Model Titanmagnetics® Zubehör Positionierhilfe für Extrusionsmagnet
Identity
- Trade Name
- Titanmagnetics EUDAMED
- Model / Reference
- Titanmagnetics® Zubehör Positionierhilfe für Extrusionsmagnet EUDAMEDP.62.01.Y100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ESTOP6201Y100 EUDAMED
- Basic UDI-DI
- ++ESTOTIMAEXP6J EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Titanmagnetics by steco-system-technik GmbH & Co. KG — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990979 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++ESTOTIMAEXP6J | Class I | Active |
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Manufacturer
- Manufacturer
- steco-system-technik GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005648
Sources (2)
- EUDAMED 6be3abf3-b1d6-4233-ae57-358aaee289b0 61 fields · synced Jul 27, 2026
- FDA 510(k) K990979 1 fields · synced May 18, 2026