Identity
- Trade Name
- aquaplus colormix blue 8 x 50 ml FDA UDI
- Generic Name
- Earmould impression material FDA UDI
- Model / Reference
- 02452 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EDET024521 FDA UDI
- FDA Product Code
- EWD FDA UDI
- GMDN Term
- Earmould impression material FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Earmould impression material
aquaplus colormix blue 8 x 50 ml by DETAX GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earmould impression material.
- PRO3DURE PR-1 — Pro3Dure Medical · Class I
- PRO3DURE L-1 — Pro3Dure Medical · Class I
- PRO3DURE PR-1 — Pro3Dure Medical · Class I
- Impression Taking Starter Kit — WESTONE LABORATORIES, INC.
- EZ Mold 8oz Tub Set Brown — WESTONE LABORATORIES, INC. · Class I
- EZ Mold Singles 24 Pk Purple — WESTONE LABORATORIES, INC. · Class I
- EZ Mold 8oz Tub Set Blue — WESTONE LABORATORIES, INC. · Class I
- PRO3DURE L-1 — Pro3Dure Medical · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DETAX GmbH
Sources (1)
- FDA UDI 1a4549a4-59f8-4b2c-b453-8fdb044acfa9 32 fields · synced May 30, 2026