Identity
- Trade Name
- Delta-Lite®Conformable EUDAMED
- Device Name
- DELTA LITE CONFORMABLE EUDAMED
- Model / Reference
- 72270-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04042809158434 EUDAMED
- Basic UDI-DI
- 404280940035996AE EUDAMED
- Unit of Use DI
- 04042809609721 EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Cotton wool roll, sterile
The Delta-Lite Conformable device is a medical implantable solution designed for tissue engineering applications, featuring a unique human-tissue compatible design. This device boasts excellent sterility and safety features, making it an ideal choice for various medical applications.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 404280940035996AE | Class I | Active |
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Manufacturer
- Manufacturer
- BSN Medical Inc.
- EUDAMED SRN
- US-MF-000019174
- Authorised Representative
- BSN medical GmbH DE-AR-000005791
Sources (1)
- EUDAMED 26989861-09ad-4e34-a0e3-2ab1d4459cc0 61 fields · synced Jul 21, 2026