Identity
- Trade Name
- Black Foam, NPWT EUDAMEDDeRoyal FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Black Foam, NPWT EUDAMEDBlack Foam NPWT FDA UDI
- Model / Reference
- NP-201-EU EUDAMEDFDA UDI
- Description
- Black Foam NPWT FDA UDI
Identifiers
- Catalog Number
- NP-201-EU FDA UDI
- Primary DI / UDI-DI
- 00749756356633 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00749756356633 EUDAMED
- FDA Product Code
- NAC 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 I FDA UDI
- Regulation Number
- 878.4018 FDA UDI
- Market of Registration
- Netherlands 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
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Black Foam, NPWT by Deroyal Industries, Inc. — 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-00749756356633 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DeRoyal Industries, Inc.
- EUDAMED SRN
- US-MF-000002102
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED e296a9f4-db38-4e2e-8a3e-89f97e8c5a70 61 fields · synced Jul 15, 2026
- FDA UDI 02225b05-e67a-4424-8d09-0a0b538696f6 34 fields · synced May 30, 2026