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Galderma
EUDAMEDClass I (EU MDR)
Ref R607 CEModel Back Applicator
by Oscimed SA
Identity
- Trade Name
- Galderma EUDAMED
- Device Name
- Back applicator cream EUDAMED
- Model / Reference
- Back Applicator EUDAMEDR607 CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640104926085 EUDAMED
- Basic UDI-DI
- 764010492BACKAPPLICATOR8X EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Galderma by Oscimed SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 764010492BACKAPPLICATOR8X | Class I | Active |
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Manufacturer
- Manufacturer
- Oscimed SA
- EUDAMED SRN
- CH-MF-000009605
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED b7594055-c855-4f0b-a6a1-b66238fc72bf 61 fields · synced Jun 18, 2026