Identity
- Trade Name
- Eclypse Adherent Sacral EUDAMEDFDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- Eclypse Adherent Sacral EUDAMEDSuperabsorbent sacral dressing with Silfix soft silicone contact layer, 22cm X 23cm. Eclypse Adherent Sacral is an exudate management wound dressing especially designed for the sacral area. The dressing combines a Silfix soft silicone contact layer, a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate, a sub-backing layer for even exudate distribution and a non-strikethrough backing to prevent leakage. FDA UDI
- Model / Reference
- CR3986 EUDAMEDFDA UDI
- Description
- Superabsorbent sacral dressing with Silfix soft silicone contact layer, 22cm X 23cm. Eclypse Adherent Sacral is an exudate management wound dressing especially designed for the sacral area. The dressing combines a Silfix soft silicone contact layer, a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate, a sub-backing layer for even exudate distribution and a non-strikethrough backing to prevent leakage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031473988 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060031473988 EUDAMED
- FDA Product Code
- NAC FDA UDI
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4018 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
- Width — 22 Centimeter FDA UDILength — 23 Centimeter FDA UDI
Eclypse Adherent Sacral 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-05060031473988 | 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 291b2c50-0a05-4e17-866d-03c78a0760f6 61 fields · synced Jun 18, 2026
- FDA UDI 863e9ff5-2524-421f-a9c6-71519ddb823c 35 fields · synced May 30, 2026