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Accutron Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 25096-FRUModel Scavenging Circuit
by Accutron
Identity
- Trade Name
- Accutron Inc. EUDAMEDFRU, N2O Gauge, 2-4 Cyl FDA UDI
- Generic Name
- Medical gas pipeline system FDA UDI
- Model / Reference
- Scavenging Circuit EUDAMED25096-FRU EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 25096-FRU FDA UDI
- Primary DI / UDI-DI
- 00813830026153 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813830026153 EUDAMED
- FDA Product Code
- BXH FDA UDI
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
- GMDN Term
- Medical gas pipeline system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2610 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Accutron Inc. by Accutron — Class IIa — 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-00813830026153 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 9bad6d94-e9af-4247-9b73-6b2e85439f66 61 fields · synced Jun 8, 2026
- FDA UDI 83bcd162-63fd-4489-aab9-5e5f2716d60c 33 fields · synced May 30, 2026