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medicalprint shell blue opaque 1000g
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 04164Model Colour variants
Identity
- Trade Name
- MedicalPrint 385 blau-opak 1.000 g EUDAMEDmedicalprint shell blue opaque 1000g FDA UDI
- Generic Name
- Earmould, custom-made FDA UDI
- Model / Reference
- 04164 EUDAMEDFDA UDIColour variants EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET041641 EUDAMEDEDET041641 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
medicalprint shell blue opaque 1000g by DETAX GmbH & Co. KG — 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 & Co. KG
Sources (2)
- FDA UDI 850fea66-6ee1-4c51-b0e2-d5a34fb7d7de 32 fields · synced Jun 18, 2026
- EUDAMED 4bb52f4e-fab5-436a-bc50-19e9751086a0 61 fields · synced Jun 18, 2026