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Medikro Calibration Syringe, volume 3000 ml
EUDAMEDFDA UDIClass I (EU MDR)
Ref M9474
by Medikro Oy
Identity
- Trade Name
- Medikro Calibration Syringe, volume 3000 ml EUDAMEDM9474, Medikro® Calibration Syringe, 3000 ml FDA UDI
- Generic Name
- Spirometer/pulmonary function analyser syringe FDA UDI
- Model / Reference
- M9474 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06420099000387 EUDAMEDFDA UDI
- Basic UDI-DI
- 6420099M9474LJ EUDAMED
- Direct Marketing DI
- 06420099000387 EUDAMED
- FDA Product Code
- BXW FDA UDI
- EMDN Code
- Z12150199 SPIROMETRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Spirometer/pulmonary function analyser syringe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.1870 FDA UDI
- Market of Registration
- Finland 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Medikro Calibration Syringe, volume 3000 ml by Medikro Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6420099M9474LJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (2)
- EUDAMED aa39424d-ffac-46ef-9c48-3ff32dfdcb51 61 fields · synced Jun 20, 2026
- FDA UDI d8073ded-5a52-44c5-8623-1a0aee90c430 32 fields · synced May 30, 2026