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Accutron Inc.
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 36100-PEUModel Analog Flowmeter
by Accutron
Identity
- Trade Name
- Accutron Inc. EUDAMEDUltra PC % Package B, PEU Model FDA UDI
- Generic Name
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
- Model / Reference
- Analog Flowmeter EUDAMED36100-PEU EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 36100-PEU FDA UDI
- Primary DI / UDI-DI
- 00813830026252 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813830026252 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-00813830026252 | 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 95c7a5c0-ac8f-4c0d-ac27-61d1371328e8 61 fields · synced Jun 8, 2026
- FDA UDI 31f3bd7a-78e6-475f-9fcd-8fae9546212e 34 fields · synced May 30, 2026