Identity
- Trade Name
- Physiotulle Ag EUDAMED
- Device Name
- Physiotulle Ag EUDAMED
- Model / Reference
- CR4495 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031482447 EUDAMED
- Basic UDI-DI
- B-05060031482447 EUDAMED
- EMDN Code
- M04040801 SILVER DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Denmark 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Physiotulle Ag by Brightwake Limited — 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-05060031482447 | Class III | 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 (1)
- EUDAMED bd10d11b-b954-4305-94b4-1f66456e8ba3 61 fields · synced Jun 18, 2026