Identity
- Trade Name
- Deflux Gel for Injection EUDAMED
- Device Name
- DEFLUX SYRINGE (1ML) EUDAMED
- Model / Reference
- 011503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850004725047 EUDAMED
- Basic UDI-DI
- B-00850004725047 EUDAMED
- EMDN Code
- P080302 URETERAL PROSTHESES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Deflux Gel for Injection by Palette Life Sciences — 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-00850004725047 | Class III | Active |
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Manufacturer
- Manufacturer
- Palette Life Sciences Inc.
- EUDAMED SRN
- US-MF-000014009
- Authorised Representative
- Scandinavian Regulatory Services AB SE-AR-000004526
Sources (1)
- EUDAMED 5f4dc71c-d27b-4241-82c7-efda8e89f19a 61 fields · synced Jul 14, 2026