Identity
- Trade Name
- Insufflator EUDAMEDFDA UDI
- Generic Name
- Laparoscopic insufflator FDA UDI
- Device Name
- Insufflator EUDAMEDThe product is composed of a host and accessories (high pressure tube, pneumoperitoneum tube), and accessories are optional. The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. FDA UDI
- Model / Reference
- SL101 EUDAMEDFDA UDI
- Description
- The product is composed of a host and accessories (high pressure tube, pneumoperitoneum tube), and accessories are optional. The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381251357 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125017A8N EUDAMED
- Direct Marketing DI
- 06971381251357 EUDAMED
- 510(k) Number
- K222812 FDA UDI
- FDA Product Code
- HIF 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 UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Insufflator by Scivita Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222812 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697138125017A8N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 5c0f3f00-f67e-4196-b47c-a5e50056d14a 61 fields · synced Jul 29, 2026
- FDA UDI 16c2c72b-255f-4f33-b768-8e5f4d6e7957 35 fields · synced May 30, 2026
- FDA 510(k) K222812 1 fields · synced May 18, 2026