Identity
- Trade Name
- PneuView XE EUDAMEDFDA UDI
- Generic Name
- Laparoscopic plume filter FDA UDI
- Device Name
- PneuView XE EUDAMEDLAPAROSCOPIC SMOKE ELIMINATION DEVICE FDA UDI
- Model / Reference
- 9660-XE EUDAMEDFDA UDI
- Description
- LAPAROSCOPIC SMOKE ELIMINATION DEVICE FDA UDI
Identifiers
- Catalog Number
- 9660-XE FDA UDI
- Primary DI / UDI-DI
- 00852588007045 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00852588007045 EUDAMED
- FDA Product Code
- FCZ FDA UDI
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Laparoscopic plume filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
PneuView XE by Lexion Medical LLC — Class I — 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-00852588007045 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lexion Medical LLC
- EUDAMED SRN
- US-MF-000033626
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (2)
- EUDAMED dd3c4cf7-1afa-4f79-b27b-71691e3ece6c 61 fields · synced Jul 9, 2026
- FDA UDI b4ba4b64-5687-4ec6-8fc6-8812aa9860e1 34 fields · synced May 30, 2026