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Gilbert
EUDAMEDClass I (EU MDR)
Ref GIL-612648 / ACL 6117513 - IG 612648ETU02- NR 10-25Model 39-0390 / 39-0391 / 39-0392 / 39-0395 / 39-1391
Identity
- Trade Name
- Gilbert EUDAMED
- Device Name
- Clear Watershield Heavy Duty adhesive bandages EUDAMED
- Model / Reference
- 39-0390 / 39-0391 / 39-0392 / 39-0395 / 39-1391 EUDAMEDGIL-612648 / ACL 6117513 - IG 612648ETU02- NR 10-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03518646126482 EUDAMED
- Basic UDI-DI
- 48079990M157QQ EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Gilbert by Aso Philippines, Inc. — 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 | 48079990M157QQ | Class I | Active |
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Manufacturer
- Manufacturer
- Aso Philippines, Inc.
- EUDAMED SRN
- PH-MF-000027714
- Authorised Representative
- Aso Europe BV NL-AR-000004377
Sources (1)
- EUDAMED 9414ad94-334c-4ee4-80e5-e5c61a29da6e 61 fields · synced Jul 26, 2026