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Insufflator Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IN-12-4Model AVN-T120, AVN-T150, AVN-S120, AVN-S150Ref IN-15-4
Identity
- Trade Name
- INSUFFLATOR NEEDLE EUDAMEDThe OR Company-InsufflatOR Needle FDA UDI
- Generic Name
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
- Device Name
- Veress Needle EUDAMEDINSUFFLATOR NEEDLE EUDAMEDInsufflation needle 12cm FDA UDIInsufflation needle 15cm FDA UDI
- Model / Reference
- AVN-T120, AVN-T150, AVN-S120, AVN-S150 EUDAMEDIN-12-4 EUDAMEDFDA UDIIN-15-4 EUDAMEDFDA UDI
- Description
- Insufflation needle 12cm FDA UDIInsufflation needle 15cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711605991643 EUDAMEDFDA UDI04711605991674 EUDAMEDFDA UDI
- Basic UDI-DI
- 471160599AVN0186 EUDAMEDB-04711605991643 EUDAMEDB-04711605991674 EUDAMED
- FDA Product Code
- HIF FDA UDI
- EMDN Code
- K0104 VERESS NEEDLES EUDAMED
- GMDN Term
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Market of Registration
- Germany EUDAMEDFrance 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 120 Millimeter FDA UDILength — 150 Millimeter FDA UDI
Insufflator Needle by Advanced Medical Design Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 471160599AVN0186 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 471160599AVN0186 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Advanced Medical Design Co., Ltd.
- EUDAMED SRN
- TW-MF-000019772
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED d3717e88-03e7-41d8-b474-45e096616f6a 61 fields · synced Sep 18, 2026
- FDA UDI c333cf6d-6cf2-45da-bc96-609327781cf5 35 fields · synced May 30, 2026
- FDA UDI 5875f98c-12c5-48d0-9e07-94bac4f84343 35 fields · synced May 30, 2026
- EUDAMED 0251b902-b38f-4011-b5be-7f8c91c6c20b 61 fields · synced Jul 10, 2026
- EUDAMED a2719e60-a6d7-4a94-aa9e-c51621ea4b15 61 fields · synced Jul 17, 2026
- EUDAMED 73aecd81-e12f-4fe5-ac9a-ba095d43358c 61 fields · synced Sep 18, 2026