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freeprint shell beige 1000 g
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 03747Model Colour variants
by DETAX GmbH
Identity
- Trade Name
- freeprint shell beige 1000 g EUDAMEDFDA UDI
- Generic Name
- Earmould, custom-made FDA UDI
- Model / Reference
- 03747 EUDAMEDFDA UDIColour variants EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET037471 EUDAMEDEDET037471 FDA UDI
- Basic UDI-DI
- ++EDET0815Y EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
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, custom-made
freeprint shell beige 1000 g by DETAX GmbH — 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
- DETAX GmbH
Sources (2)
- FDA UDI 4c5c8222-c167-4285-bbc0-b24ebb4db2b5 32 fields · synced Sep 18, 2026
- EUDAMED d754126b-5365-425c-9f89-36c530c98365 61 fields · synced Sep 18, 2026