Identity
- Trade Name
- Carilex EUDAMEDNA FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Negative Pressure Wound Therapy System (Dressing Kit) EUDAMEDVT Dressing Kit TS L Carilex FDA UDI
- Model / Reference
- S1001-2220 EUDAMEDFDA UDI
- Description
- VT Dressing Kit TS L Carilex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873695201 EUDAMEDFDA UDI
- Basic UDI-DI
- 471361609S1XXXCJ EUDAMED
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Carilex by Carilex Medical, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471361609S1XXXCJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Carilex Medical, Inc
- EUDAMED SRN
- TW-MF-000002145
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1c86b061-a2b5-4cde-a13c-892fab9a09d6 61 fields · synced Jun 8, 2026
- FDA UDI b16334c2-3f7b-4560-a69c-a89d7a8581ee 33 fields · synced May 30, 2026