Identity
- Trade Name
- Siltape EUDAMEDFDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, silicone FDA UDI
- Device Name
- Siltape EUDAMEDSoft Silicone Perforated Tape, 2cm X 3m. Siltape is a soft silicone fixation tape delivered on a roll with perforations for ease of use. Siltape is made from Silicone that is gentler on removal unlike other adhesives that may cause tissue damage when removed and is particularly useful in patients with very thin, friable skin. FDA UDI
- Model / Reference
- CR3938 EUDAMEDFDA UDI
- Description
- Soft Silicone Perforated Tape, 2cm X 3m. Siltape is a soft silicone fixation tape delivered on a roll with perforations for ease of use. Siltape is made from Silicone that is gentler on removal unlike other adhesives that may cause tissue damage when removed and is particularly useful in patients with very thin, friable skin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031473308 EUDAMEDFDA UDI
- Basic UDI-DI
- 506003147SiltapeER EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Meter FDA UDIWidth — 2 Centimeter FDA UDI
Siltape by Brightwake Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506003147SiltapeER | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 b5ad085c-ea42-49ee-bf69-3f2b721d39e1 61 fields · synced Jun 19, 2026
- FDA UDI d3f8628d-1522-4a74-9ac8-1e2d89de0b90 35 fields · synced May 30, 2026