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
- CR4493 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
- 05060031482003 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060031482003 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 20 Gram FDA UDI
Activon Tube by Brightwake Limited — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060031482003 | 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 d9e45c82-d70a-4098-a25a-0a1b83ccd6b0 61 fields · synced Jul 9, 2026
- FDA UDI 45a7e901-74ec-4030-b6e2-8eaf5884bc8d 36 fields · synced May 30, 2026