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Tethys H10
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref M7E200200, M7E200300, M7E200321, M7E200320, M7E200310Model Washer-disinfectors employing thermal disinfection and/or ultrasound, for medical purpose
by CEFLA s.c.
Identity
- Trade Name
- Tethys H10 EUDAMEDmocom FDA UDI
- Generic Name
- Ultrasonic-cleaning water bath FDA UDI
- Device Name
- Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgical instruments able to resist to a temperature of at least 80°C. FDA UDI
- Model / Reference
- Washer-disinfectors employing thermal disinfection and/or ultrasound, for medical purpose EUDAMEDM7E200200, M7E200300, M7E200321, M7E200320, M7E200310 EUDAMEDTethys H10 FDA UDI
- Description
- Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgical instruments able to resist to a temperature of at least 80°C. FDA UDI
Identifiers
- Catalog Number
- M7E200310 FDA UDI
- Primary DI / UDI-DI
- 08033837931331 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793STUWASHDB0015F EUDAMED
- Direct Marketing DI
- 08033837931331 EUDAMED
- FDA Product Code
- MEC FDA UDIMDZ FDA UDI
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
- GMDN Term
- Ultrasonic-cleaning water bath FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6992 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Surgical utensil washer/disinfector
Tethys H10 by CEFLA s.c. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 803383793STUWASHDB0015F | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (3)
- EUDAMED 149b02eb-daed-4358-927b-9fdd987b5fc4 61 fields · synced Jun 19, 2026
- FDA UDI 7e41df0c-1920-4d84-a681-944f689cf3eb 36 fields · synced May 30, 2026
- EUDAMED 149b02eb-daed-4358-927b-9fdd987b5fc4-1 61 fields · synced Jun 9, 2026