Identity
- Trade Name
- FibriJet Regulator EUDAMEDFibriJet FDA UDI
- Generic Name
- Surgical air pipeline regulator FDA UDI
- Device Name
- Regulator EUDAMEDFIBRIJET REGULATOR FDA UDI
- Model / Reference
- SA-6030 EUDAMEDFDA UDI
- Description
- FIBRIJET REGULATOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634021785 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00815634021785 EUDAMED
- FDA Product Code
- CAN FDA UDI
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
- GMDN Term
- Surgical air pipeline regulator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2700 FDA UDI
- Market of Registration
- Belgium 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
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
FibriJet Regulator by Micromedics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00815634021785 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 38ff3a38-6b79-4b54-a78f-6587a4923772 61 fields · synced Jun 19, 2026
- FDA UDI 4a54f799-6559-48eb-b065-010b25efd6ab 33 fields · synced May 30, 2026