Identity
- Trade Name
- AP50/30 High-Flow Insufflator EUDAMEDAP50/30 FDA UDI
- Generic Name
- Laparoscopic insufflator FDA UDI
- Device Name
- AP50/30 High Flow Insufflator EUDAMEDHigh Flow Insufflator FDA UDI
- Model / Reference
- 4100 EUDAMEDFDA UDI
- Description
- High Flow Insufflator FDA UDI
Identifiers
- Catalog Number
- 4100 FDA UDI
- Primary DI / UDI-DI
- 00852588007229 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00852588007229 EUDAMED
- 510(k) Number
- K170799 FDA UDI
- FDA Product Code
- HIF FDA UDIGCJ FDA UDIOSV FDA UDI
- EMDN Code
- Z12029008 GAS INFLATORS EUDAMED
- GMDN Term
- Laparoscopic insufflator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1730 FDA UDI876.1500 FDA UDI
- Market of Registration
- France 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
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AP50/30 High-Flow Insufflator by Lexion Medical LLC — 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-00852588007229 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 d181bff5-7107-496a-b4db-3ce21eca39c7 61 fields · synced Jul 15, 2026
- FDA UDI 636f9d20-4560-451e-a54a-f655ba897819 35 fields · synced May 30, 2026