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Accutron Inc.
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 26400-BWRModel Digital Flowmeter
by Accutron
Identity
- Trade Name
- Accutron Inc. EUDAMEDFlowmeter, Flexmount, Biewer FDA UDI
- Generic Name
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
- Model / Reference
- Digital Flowmeter EUDAMED26400-BWR EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 26400-BWR FDA UDI
- Primary DI / UDI-DI
- 00813830023961 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813830023961 EUDAMED
- 510(k) Number
- K970163 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
- GMDN Term
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Accutron Inc. by Accutron — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813830023961 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Accutron
- EUDAMED SRN
- US-MF-000009363
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 715d6082-9912-4089-a720-eb0377d6e7a6 61 fields · synced Jul 10, 2026
- FDA UDI 6314acdc-c562-47af-b993-5cede77c447a 34 fields · synced May 30, 2026