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Intraskan Dc And It's Variants
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 303-000134 -6Ref 303-000133-14Ref 303-000134-14Ref 303-000134-21Ref 303-000011-19Ref 303-000133-12Ref 303-000133-23Ref 303-000134-23Ref 303-000011-14Ref 303-000134-19Ref 303-000133-19Ref 303-000134 -18Ref 303-000134-8
Identity
- Device Name
- INTRASKAN DC AND IT'S VARIANTS EUDAMED
- Model / Reference
- 303-000134 -6 EUDAMED303-000133-14 EUDAMED303-000134-14 EUDAMED303-000134-21 EUDAMED303-000011-19 EUDAMED303-000133-12 EUDAMED303-000133-23 EUDAMED303-000134-23 EUDAMED303-000011-14 EUDAMED303-000134-19 EUDAMED303-000133-19 EUDAMED303-000134 -18 EUDAMED303-000134-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904269400484 EUDAMED08904269400132 EUDAMED08904269400149 EUDAMED08904269400491 EUDAMED08904269400088 EUDAMED08904269400019 EUDAMED08904269400057 EUDAMED08904269400064 EUDAMED08904269400125 EUDAMED08904269400101 EUDAMED08904269400095 EUDAMED08904269400507 EUDAMED08904269400514 EUDAMED
- Basic UDI-DI
- 890426940100173 EUDAMED
- Direct Marketing DI
- 08904269400484 EUDAMED08904269400132 EUDAMED08904269400149 EUDAMED08904269400491 EUDAMED08904269400088 EUDAMED08904269400019 EUDAMED08904269400057 EUDAMED08904269400064 EUDAMED08904269400125 EUDAMED08904269400101 EUDAMED08904269400095 EUDAMED08904269400507 EUDAMED08904269400514 EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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
Category: Dental digital imaging sensor, intraoral
Intraskan Dc And It's Variants by Skanray Technologies Limited — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K103579 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 890426940100173 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Skanray Technologies Limited
- EUDAMED SRN
- IN-MF-000034819
- Authorised Representative
- SKANRAY EUROPE SRL IT-AR-000013034
Sources (14)
- EUDAMED f9e753da-7417-4a7e-9f93-5811dd579f6b 61 fields · synced Aug 2, 2026
- EUDAMED 51bbac8c-1b6f-4184-ae7c-7cd26b939ac0 61 fields · synced May 16, 2026
- EUDAMED 5cb50f74-7cdc-4f00-a381-36fbbf060226 61 fields · synced May 16, 2026
- EUDAMED bfb7b026-68df-4bfe-b9ee-1666070d7e4a 61 fields · synced May 16, 2026
- EUDAMED 0fbfaea7-2aed-4fe4-ad99-b610a09c902a 61 fields · synced May 16, 2026
- EUDAMED c1dbc99a-cf9c-495d-8d5d-b7e1732442ac 61 fields · synced May 17, 2026
- EUDAMED 7ef51bbc-dc0e-43ab-b2cd-0c9a8f73828c 61 fields · synced May 17, 2026
- EUDAMED dc213996-e598-4e28-a342-a9eba1bb36c8 61 fields · synced May 17, 2026
- EUDAMED 6c783fc9-c06f-4771-af86-1081ba49aac4 61 fields · synced May 18, 2026
- EUDAMED 2402977a-b919-4e65-bf6c-b03e226b2a54 61 fields · synced May 18, 2026
- EUDAMED a5f5405e-5ed8-4d77-893a-ca7ba1756326 61 fields · synced May 18, 2026
- EUDAMED 7c3fbd1c-9eb6-43d3-8364-3dbc422a4431 61 fields · synced May 18, 2026
- EUDAMED d51d7b1f-bb96-4b13-978a-6a32d6b1b5b3 61 fields · synced May 19, 2026
- FDA 510(k) K103579 1 fields · synced May 18, 2026