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Actilite
EUDAMEDClass IIb (EU MDR)
Ref CR3852Ref CR4366Ref CR3849Ref CR4368Ref CR4281
Identity
- Trade Name
- Actilite EUDAMED
- Device Name
- Actilite EUDAMED
- Model / Reference
- CR3852 EUDAMEDCR4366 EUDAMEDCR3849 EUDAMEDCR4368 EUDAMEDCR4281 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031471502 EUDAMED05060031479881 EUDAMED05060031471465 EUDAMED05060031470178 EUDAMED05060031478426 EUDAMED
- Basic UDI-DI
- B-05060031471502 EUDAMEDB-05060031479881 EUDAMEDB-05060031471465 EUDAMEDB-05060031470178 EUDAMEDB-05060031478426 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Actilite by Brightwake Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-05060031471502 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Brightwake Limited
- EUDAMED SRN
- GB-MF-000012039
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (5)
- EUDAMED 54a63652-3655-4953-876d-569c03e8ead4 61 fields · synced Sep 30, 2026
- EUDAMED 95f42a44-dc53-4845-b0b2-fd99ae594155 61 fields · synced May 16, 2026
- EUDAMED 06f80cf1-4204-4ccb-9e9a-33d456f53b51 61 fields · synced May 17, 2026
- EUDAMED 91835373-28d7-4584-830c-e4f50438b5ce 61 fields · synced May 17, 2026
- EUDAMED 92064ad0-0a8f-4a0e-bb9b-3b0c3ac1473f 61 fields · synced May 18, 2026