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Serenity T Vaporizer BAXTER SEV Safe-T-Seal BG, HR, CS, SK, SR
EUDAMEDClass IIb (EU MDR)
Ref TS40B04NN00Model Serenity S, Serenity T
Identity
- Trade Name
- Serenity T Vaporizer BAXTER SEV Safe-T-Seal BG, HR, CS, SK, SR EUDAMED
- Device Name
- Serenity S, Serenity T EUDAMED
- Model / Reference
- Serenity S, Serenity T EUDAMEDTS40B04NN00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953131480 EUDAMED
- Basic UDI-DI
- 08406821BUG004777P EUDAMED
- EMDN Code
- Z1203010180 ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Serenity T Vaporizer BAXTER SEV Safe-T-Seal BG, HR, CS, SK, SR by Datex-Ohmeda Inc. — 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 | 08406821BUG004777P | Class IIb | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000014656
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED a9158baa-7c48-463e-bd5d-b7f0d8588f2b 61 fields · synced Oct 5, 2026