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Tec 820 Sev
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1177-9820-SEVModel TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV
Identity
- Trade Name
- TEC 820 SEV EUDAMEDTEC FDA UDI
- Generic Name
- Sevoflurane anaesthesia vaporizer FDA UDI
- Device Name
- TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV EUDAMEDTEC 820 SEV FDA UDI
- Model / Reference
- TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV EUDAMED1177-9820-SEV EUDAMED820 SEV FDA UDI
- Description
- TEC 820 SEV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682124720 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00339HN EUDAMED
- 510(k) Number
- K172702 FDA UDI
- FDA Product Code
- CAD FDA UDI
- EMDN Code
- Z1203010180 ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Sevoflurane anaesthesia vaporizer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5880 FDA UDI
- Market of Registration
- France 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
MR Conditional FDA UDI
Tec 820 Sev by Datex-Ohmeda Inc. — 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 | 8406821BUG00339HN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000014656
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 30ee960e-f1b2-4607-9f0e-698883eb9d3b 61 fields · synced Jul 9, 2026
- FDA UDI 1b697565-0ea9-48bd-a9cd-d8ce1477174e 35 fields · synced May 29, 2026