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Accutron Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 43004Model Scavenging Circuit
by Accutron
Identity
- Trade Name
- Accutron Inc. EUDAMEDScavenging Circuit II, ClearView RFS FDA UDI
- Generic Name
- Anaesthesia workstation gas scavenger FDA UDI
- Model / Reference
- Scavenging Circuit EUDAMED43004 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 43004 FDA UDI
- Primary DI / UDI-DI
- 00813830023909 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813830023909 EUDAMED
- 510(k) Number
- K033503 FDA UDI
- FDA Product Code
- CBN FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Anaesthesia workstation gas scavenger FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5430 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
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-00813830023909 | 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 340e278b-10ce-4afd-a947-a78bb1a9eceb 61 fields · synced Aug 1, 2026
- FDA UDI c1fda362-cbf3-498d-9c75-38d36cf7dcff 34 fields · synced May 29, 2026