Identity
- Trade Name
- audioprint GR-10 EUDAMEDPRO3DURE GR-10 FDA UDI
- Generic Name
- Earmould, custom-made FDA UDI
- Device Name
- Long-Term Earmold Resins EUDAMEDaudioprint GR-10 FDA UDI
- Model / Reference
- 12140201 EUDAMEDA1000885 EUDAMED1kg - Neon pink translucent FDA UDI
- Description
- audioprint GR-10 FDA UDI
Identifiers
- Catalog Number
- A1000885 FDA UDI
- Primary DI / UDI-DI
- EPRCA1000885 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EPRC12140201BF EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Earmould, custom-made FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
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: Earmould, custom-made
Pro3dure Gr-10 by Pro3Dure Medical — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pro3Dure Medical
Sources (2)
- FDA UDI 4860afce-2c9a-419e-93df-88457a196c08 36 fields · synced Jul 8, 2026
- EUDAMED ba874b4b-2401-4ad0-9c6e-7ad179d1a66f 61 fields · synced Jul 8, 2026