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Insufflator(with Insufflation Tube and Gas Filter)
EUDAMEDClass IIb (EU MDR)
Ref 4050039
Identity
- Trade Name
- Insufflator(with Insufflation Tube and Gas Filter) EUDAMED
- Device Name
- Insufflator (with Insufflation Tube and Gas Filter) EUDAMED
- Model / Reference
- 4050039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031299191 EUDAMED
- Basic UDI-DI
- 697303129WS01P01KL EUDAMED
- EMDN Code
- Z12029008 GAS INFLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The insufflator (OPTO-IFL1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Insufflator(with Insufflation Tube and Gas Filter) by Guangdong Optomedic Technologies, Inc. — Class IIb — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697303129WS01P01KL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong OptoMedic Technologies, Inc.
- EUDAMED SRN
- CN-PR-000043365
Sources (1)
- EUDAMED 74f789c6-a9d7-491b-a1e5-a3603bcb942f 61 fields · synced Jun 14, 2026