Identity
- Trade Name
- PRO3DURE GR-1 FDA UDI
- Generic Name
- Earmould, custom-made FDA UDI
- Device Name
- audioprint GR-1 FDA UDI
- Model / Reference
- 1kg - clear-transparent FDA UDI
- Description
- audioprint GR-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EPRCA1000300 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Earmould, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Earmould, custom-made
Pro3dure Gr-1 by Pro3Dure Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earmould, custom-made.
- Lucid® — HEARING LAB TECHNOLOGY, LLC · Class I
- Biopor® AB — Dreve Otoplastik GmbH · Class I
- Biopor® AB — Dreve Otoplastik GmbH · Class I
- Biopor® AB monitoring — Dreve Otoplastik GmbH · Class I
- Biopor® AB Xtreme — Dreve Otoplastik GmbH · Class I
- Biopor® AB — Dreve Otoplastik GmbH · Class I
- FotoTec® SL.E — Dreve Otoplastik GmbH · Class I
- FotoTec® DLP.C — Dreve Otoplastik GmbH · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pro3Dure Medical
Sources (1)
- FDA UDI e0eed86a-d6f8-40d5-82bc-a8df83c24e71 35 fields · synced May 30, 2026