Identity
- Trade Name
- Recubrimiento protector (G2) Refill 5x50 EUDAMED
- Device Name
- Bluephase Sleeves EUDAMED
- Model / Reference
- 608554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208484441 EUDAMED
- Basic UDI-DI
- 76152081XSLEE0013H EUDAMED
- Unit of Use DI
- 07615208506051 EUDAMED
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Liechtenstein 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: Radiation/mechanical corneal shield, reusable
Recubrimiento protector (G2) Refill 5x50 by Ivoclar Vivadent AG — Class I — 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 | 76152081XSLEE0013H | Class I | Active |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED bf43f6d8-51be-4d04-aabd-6b942dcc41e2 61 fields · synced Jun 18, 2026