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Medis
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AC0100PModel AC0100B，AC0100R，AC0100P
Identity
- Trade Name
- AccuCuff EUDAMEDMedis FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- Cuff Pressure Indicators EUDAMEDCuff Pressure Indicator, with Luer Lock, Pink, Paediatric, Tracheal FDA UDI
- Model / Reference
- AC0100P EUDAMEDFDA UDIAC0100B，AC0100R，AC0100P EUDAMED
- Description
- Cuff Pressure Indicator, with Luer Lock, Pink, Paediatric, Tracheal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06920687303604 EUDAMEDFDA UDI
- Basic UDI-DI
- 69206873AC001EM EUDAMED
- 510(k) Number
- K182548 FDA UDI
- FDA Product Code
- BSK FDA UDI
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Airway pressure monitor, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5750 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Airway pressure monitor, non-powered
Medis by Tianjin Medis Medical Device Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tianjin Medis Medical Device Co., Ltd.
Sources (2)
- FDA UDI 379de866-c2c6-4b0a-92c1-59bab63b582b 35 fields · synced Oct 6, 2026
- EUDAMED 8de6f60b-9a24-428f-98f8-327e8c52b900 61 fields · synced Oct 6, 2026