Identity
- Trade Name
- FibriJet EUDAMED
- Device Name
- SINGLE CANNULA EXTENDED APPLICATOR EUDAMED
- Model / Reference
- SA-3648 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10815634021652 EUDAMED
- Basic UDI-DI
- B-10815634021652 EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FibriJet by Micromedics, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10815634021652 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED bdc1afde-d81a-4bfd-b60f-132b3859497a 61 fields · synced May 23, 2026