Identity
- Trade Name
- 9100c NXT EUDAMED
- Device Name
- Anesthesia Machine EUDAMED
- Model / Reference
- 9100c NXT EUDAMEDM9100175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682134910 EUDAMED
- Basic UDI-DI
- 8406821BUG00167HH EUDAMED
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
9100c NXT by GE Medical Systems CO. Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00167HH | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 0fbbcc63-138e-4933-a4a5-9e3ed867121e 61 fields · synced Jul 19, 2026