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Transeal TR Dressing Patch2 1/2 X 2 3/4
EUDAMEDFDA UDIClass I (EU MDR)
Ref 46-302TR-EURef 46-302X-EU
Identity
- Trade Name
- Transeal TR Dressing Patch2 1/2 X 2 3/4 EUDAMEDTranseal TR Dressing Patch2 1/2 X 2 3/4 Transeal Maxx Patch2 1/2 X 2 3/4 (6.4 cm x 7 cm) EUDAMEDDeRoyal FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Transeal TR Dressing Patch2 1/2 X 2 3/4 EUDAMEDFDA UDITranseal Maxx Patch2 1/2 X 2 3/4 (6.4 cm x 7 cm) EUDAMED
- Model / Reference
- 46-302TR-EU EUDAMEDFDA UDI46-302X-EU EUDAMED
- Description
- Transeal TR Dressing Patch2 1/2 X 2 3/4 FDA UDI
Identifiers
- Catalog Number
- 46-302TR-EU FDA UDI
- Primary DI / UDI-DI
- 00749756379793 EUDAMEDFDA UDI00749756379809 EUDAMED
- Basic UDI-DI
- B-00749756379793 EUDAMEDB-00749756379809 EUDAMED
- FDA Product Code
- NAD FDA UDI
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, reusable
Transeal TR Dressing Patch2 1/2 X 2 3/4 by Deroyal Industries, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00749756379793 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (3)
- EUDAMED ba208cfb-3ec9-4702-832c-f09536c5d8c8 61 fields · synced Jul 13, 2026
- EUDAMED 1d6fc60f-bedd-41f0-9c64-6cff64c36eab 61 fields · synced May 18, 2026
- FDA UDI 9d8c7dad-a5ac-4405-b1e9-f2f7d02bdf03 35 fields · synced May 30, 2026