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REVOLAX™ with Lidocaine
EUDAMEDClass III (EU MDR)
Ref REVOLAX™ FINE with Lidocaine
Identity
- Device Name
- REVOLAX™ with Lidocaine EUDAMED
- Model / Reference
- REVOLAX™ FINE with Lidocaine EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8809427070175A3 EUDAMED
- Basic UDI-DI
- B-8809427070175A3 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
REVOLAX™ with Lidocaine by Across Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-8809427070175A3 | Class III | Active |
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Manufacturer
- Manufacturer
- Across Co., Ltd.
- EUDAMED SRN
- KR-MF-000012936
- Authorised Representative
- AeMi World e.K DE-AR-000007704
Sources (1)
- EUDAMED 48c8adab-81c5-4e2f-9d2d-4d21b7706b3f 61 fields · synced Jun 19, 2026