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i-ROCK
EUDAMEDClass IIa (EU MDR)
Ref IRON8Ref IROSA51Ref IROSETRef IROSBLRef IROO3Ref IROETRef IROC2Ref IRON4Ref IROSB21Ref IROB2Ref IROA3Ref IROSA31Ref IROSA11Ref IROO2
Identity
- Trade Name
- i-ROCK EUDAMED
- Device Name
- Light curing nano hybrid composite based on zirconium EUDAMED
- Model / Reference
- IRON8 EUDAMEDIROSA51 EUDAMEDIROSET EUDAMEDIROSBL EUDAMEDIROO3 EUDAMEDIROET EUDAMEDIROC2 EUDAMEDIRON4 EUDAMEDIROSB21 EUDAMEDIROB2 EUDAMEDIROA3 EUDAMEDIROSA31 EUDAMEDIROSA11 EUDAMEDIROO2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178008107 EUDAMED04772178009180 EUDAMED04772178009050 EUDAMED04772178009067 EUDAMED04772178009005 EUDAMED04772178009012 EUDAMED04772178002488 EUDAMED04772178008091 EUDAMED04772178009197 EUDAMED04772178002464 EUDAMED04772178002426 EUDAMED04772178009173 EUDAMED04772178009159 EUDAMED04772178008992 EUDAMED
- Basic UDI-DI
- 4772178ML01PBRMV3 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
i-ROCK by UAB "Medicinos linija" — 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 | 4772178ML01PBRMV3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- UAB "Medicinos linija"
- EUDAMED SRN
- LT-MF-000002719
Sources (14)
- EUDAMED a18bb968-9758-4096-a8de-3c2375f7b432 61 fields · synced Oct 7, 2026
- EUDAMED e0187c81-e1d2-423d-84c6-09a069d2d1c4 61 fields · synced May 17, 2026
- EUDAMED 8ff6e1b9-f68c-4453-b65c-3754bcff5f00 61 fields · synced May 17, 2026
- EUDAMED 62e50503-480c-4e92-b7c7-ce00c5d9ef6e 61 fields · synced May 17, 2026
- EUDAMED ffe24a0a-3124-456c-a227-9cd6455c9ba9 61 fields · synced May 17, 2026
- EUDAMED eee386d4-97b9-4738-ab0b-3fc051c75d53 61 fields · synced May 18, 2026
- EUDAMED 46da642c-ac92-4ef3-8c6b-dd762c7be16f 61 fields · synced May 18, 2026
- EUDAMED 361af9bf-c385-4e0b-b662-33eb9c5151b0 61 fields · synced May 18, 2026
- EUDAMED 75829ac7-cc2e-48a8-a136-1f655540c7a4 61 fields · synced May 18, 2026
- EUDAMED 82047f4d-96eb-4345-bc29-56d14838d532 61 fields · synced May 18, 2026
- EUDAMED 49d5816b-546a-479f-b338-5ad18b830e39 61 fields · synced May 18, 2026
- EUDAMED b5570f5e-b3c4-484c-b931-8c63d1f7622a 61 fields · synced May 18, 2026
- EUDAMED 16ac5570-5500-4e12-a171-05a9334e976a 61 fields · synced May 18, 2026
- EUDAMED afb78436-46f5-418b-a30e-e76f8a6d922a 61 fields · synced May 19, 2026