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Aurora Boreale
EUDAMEDClass IIa (EU MDR)
Ref LUB-100
by Aqua Medi̇kal Tibbi̇ Araç Ve Gereç İnş. San. Diş Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- Aurora Boreale EUDAMED
- Device Name
- Aurora Boreale Lubricant Gel 100ml EUDAMED
- Model / Reference
- LUB-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684936800457 EUDAMED
- Basic UDI-DI
- B-08684936800457 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
No
EUDAMED
Aurora Boreale by Aqua Medi̇kal Tibbi̇ Araç Ve Gereç İnş. San. Diş Ti̇c. Ltd. Şti̇. — Class IIa — 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-08684936800457 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000023642
Sources (1)
- EUDAMED aa82f2d6-ebb5-4a1a-8bb8-d98f488efa8b 61 fields · synced Oct 7, 2026