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TMR-ZFill10. LOW FLOW 3 pcs. PACK A3
EUDAMEDClass IIa (EU MDR)
Ref TMR-Z Fill10.Model Dental ResinRef TMR-ZFill10.
Identity
- Trade Name
- TMR-ZFill10. LOW FLOW 3 pcs. PACK A3 EUDAMEDTMR-ZFill10. FLOW 3 pcs. PACK A3.5 EUDAMEDTMR-ZFill10. LOW FLOW 3 pcs. PACK A3.5 EUDAMED
- Device Name
- TMR-Z Fill 10. EUDAMED
- Model / Reference
- Dental Resin EUDAMEDTMR-Z Fill10. EUDAMEDTMR-ZFill10. EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560231207303 EUDAMED04560231207280 EUDAMED04560231207310 EUDAMED
- Basic UDI-DI
- 456023117D10B102N003UX EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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 composite resin
TMR-ZFill10. LOW FLOW 3 pcs. PACK A3 by Yamakin Co., Ltd. — 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 | 456023117D10B102N003UX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Yamakin Co., Ltd.
- EUDAMED SRN
- JP-MF-000011382
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 608fc806-1556-4c32-91c8-97703aa92bb3 61 fields · synced Oct 6, 2026
- EUDAMED a6499c50-7ad4-4df0-b6a8-554dbe7358fa 61 fields · synced May 17, 2026
- EUDAMED 07226f44-1292-4338-a5c4-f43edeb959ec 61 fields · synced May 18, 2026