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MC 3FP-S Spritzekopf (gerade) / US-Version
EUDAMEDClass IIa (EU MDR)
Ref 798.200.USModel MC 3FP SpritzeRef 798.300.33.USRef 798.300.29.US MC 3FP-S Spritzekopf (gerade) / US-VersionRef 798.300.USRef 798.200.21.USRef 798.300.21.US
Identity
- Trade Name
- MC 3FP-S Spritzekopf (gerade) / US-Version EUDAMED
- Device Name
- MC 3FP Spritze mit Mehrwegkanüle EUDAMEDMC 3FP/3FP-S Spritze EUDAMED
- Model / Reference
- MC 3FP Spritze EUDAMED798.200.US EUDAMED798.300.33.US EUDAMED798.300.29.US MC 3FP-S Spritzekopf (gerade) / US-Version EUDAMED798.300.US EUDAMED798.200.21.US EUDAMED798.300.21.US EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9511802401019 EUDAMED+D9511802301027 EUDAMED+D9511802401025 EUDAMED+D9511802401028 EUDAMED+D9511802301013 EUDAMED+D9511802401021 EUDAMED
- Basic UDI-DI
- ++D95118024JF EUDAMED++D95118023JD EUDAMED
- Direct Marketing DI
- +D9511802301027 EUDAMED+D9511802301013 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Die MC 3FP Spritze dient bei der zahnärztlichen Behandlung zur Kühlung / Säuberung / Trocknung des Behandlungsbereiches. Mit ihr kann Wasser, Luft und Wassernebel versprüht werden 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 appliance fabrication material, ceramic
MC 3FP-S Spritzekopf (gerade) / US-Version by Mytronic GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D95118024JF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mytronic GmbH
- EUDAMED SRN
- DE-PR-000030018
Sources (6)
- EUDAMED 9d4b62c2-1672-46d2-82ac-38a4ff21f60b 61 fields · synced Aug 4, 2026
- EUDAMED 7f722c99-760f-48ed-8320-64dd8f8761c3 61 fields · synced May 17, 2026
- EUDAMED c687baa4-4d0f-409d-9333-bd9e9b9b7b30 61 fields · synced May 18, 2026
- EUDAMED dbdfa36b-cac2-4bf0-82bc-2c888d6edcf9 61 fields · synced May 19, 2026
- EUDAMED 481d87f2-b900-4b79-a078-237e8bdb620f 61 fields · synced May 19, 2026
- EUDAMED ad46e16a-7633-4e58-9a19-bf0cec326dbd 61 fields · synced May 19, 2026