Identity
- Trade Name
- Transeal Maxx EUDAMED
- Device Name
- Transeal Maxx EUDAMED
- Model / Reference
- 46-326X-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00749756379816 EUDAMED
- Basic UDI-DI
- B-00749756379816 EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Scar-management dressing, reusable
Transeal Maxx by Deroyal Industries, Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00749756379816 | Class I | Active |
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Manufacturer
- Manufacturer
- DeRoyal Industries, Inc.
- EUDAMED SRN
- US-MF-000002102
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED fc4875fe-f98e-493e-9a67-781cb3e85a90 61 fields · synced Jul 10, 2026