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MC 3FP-S Spritzekopf (abgewinkelt) / US-Version
EUDAMEDClass IIa (EU MDR)
Ref 795.200.21.USModel MC 3FP Spritze
Identity
- Trade Name
- MC 3FP-S Spritzekopf (abgewinkelt) / US-Version EUDAMEDMC 3FP-S Spritzekopf (abgewinkelt) / US Version EUDAMED
- Device Name
- MC 3FP Spritze mit Mehrwegkanüle EUDAMEDMC 3FP/3FP-S Spritze EUDAMED
- Model / Reference
- MC 3FP Spritze EUDAMED795.200.21.US EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9511802402028 EUDAMED+D9511802302028 EUDAMED
- Basic UDI-DI
- ++D95118024JF EUDAMED++D95118023JD EUDAMED
- Direct Marketing DI
- +D9511802302028 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 (abgewinkelt) / US-Version by Mytronic GmbH — Class IIa — CE/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 (2)
- EUDAMED 01c3138a-7a39-4a32-a99d-9a690a1e50b2 61 fields · synced Oct 6, 2026
- EUDAMED 98ad0cab-781f-46ba-a452-98a42bc7d674 61 fields · synced May 18, 2026