Identity
- Trade Name
- Servo-n Ventilator System EUDAMEDBase Unit SERVO-n FDA UDI
- Generic Name
- Neonatal intensive-care ventilator FDA UDI
- Device Name
- Servo -u / -n / -u MR EUDAMED
- Model / Reference
- 6688600 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710001042 EUDAMEDFDA UDI
- Basic UDI-DI
- 7325710001117R EUDAMED
- Direct Marketing DI
- 07325710001042 EUDAMED
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Neonatal intensive-care ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Sweden 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Servo-n Ventilator System by Maquet Critical Care AB — Class IIb — 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 | 7325710001117R | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet Critical Care AB
- EUDAMED SRN
- SE-MF-000001264
Sources (2)
- EUDAMED 0293cb9b-3bee-4eda-a369-05bf89ff2e94 61 fields · synced Oct 6, 2026
- FDA UDI 1c46287a-301e-46be-9b81-4e9929055474 33 fields · synced May 30, 2026