Identity
- Trade Name
- Activon Tube EUDAMEDFDA UDI
- Generic Name
- Medical honey liquid barrier dressing FDA UDI
- Device Name
- Activon Tube EUDAMED100% Medical Grade Manuka honey. Activon Tube contains 100% Medical Grade Manuka honey with no additives. This wound filler will eliminate odors and provides a moist wound healing environment that facilitates autolytic debridement. Activon Tube can be used as a wound filler for use in cavities. FDA UDI
- Model / Reference
- CR3830 EUDAMEDFDA UDI
- Description
- 100% Medical Grade Manuka honey. Activon Tube contains 100% Medical Grade Manuka honey with no additives. This wound filler will eliminate odors and provides a moist wound healing environment that facilitates autolytic debridement. Activon Tube can be used as a wound filler for use in cavities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031471182 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060031471182 EUDAMED
- 510(k) Number
- K101114 FDA UDI
- FDA Product Code
- FRO FDA UDI
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
- GMDN Term
- Medical honey liquid barrier dressing FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Weight — 25 Gram FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Activon Tube by Brightwake Limited — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060031471182 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Brightwake Limited
- EUDAMED SRN
- GB-MF-000012039
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED 677fa2e2-f929-4465-b1d6-d1621809d9b8 61 fields · synced Jul 12, 2026
- FDA UDI a58ce630-174a-47b2-8ad5-d3a1865c2440 36 fields · synced May 30, 2026