Identity
- Trade Name
- Mischkanülen braun 4:1 25 St. EUDAMEDmixing cannulas brown 4:1 25 pcs FDA UDI
- Generic Name
- Dental impression material syringe, reusable FDA UDI
- Device Name
- Dentalspritze, Abdruckmaterial EUDAMED
- Model / Reference
- 02591 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +EDET025911 EUDAMEDEDET025911 FDA UDI
- Basic UDI-DI
- ++EDET0075L EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental impression material syringe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mischkanülen braun 4:1 25 St. by DETAX GmbH & Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDET0075L | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (2)
- EUDAMED d4297bee-1b9e-4310-8866-047f229ea205 61 fields · synced Oct 6, 2026
- FDA UDI a25129b9-a488-4973-bc0f-8ca502158dd2 32 fields · synced May 30, 2026