Identity
- Trade Name
- Unimicro FDA UDI
- Generic Name
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
- Device Name
- Veress Needle EUDAMEDFDA UDI
- Model / Reference
- MND11200 EUDAMEDFDA UDI
- Description
- Veress needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955797740018 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06955797740018 EUDAMED
- FDA Product Code
- FHO 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
- 876.1500 FDA UDI
- Market of Registration
- Denmark 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
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
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
Veress Needle by Unimicro Medical Systems (shenzhen) Co., Ltd. — 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-06955797740018 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Unimicro Medical Systems (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000014590
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 647b10eb-aba7-43e3-b5c5-818784fc48ca 61 fields · synced Jul 23, 2026
- FDA UDI 2601a5c7-8d35-4000-8169-a387902581dc 33 fields · synced May 30, 2026