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Veress Needle

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref MND11500

by Unimicro Medical Systems (Shenzhen) Co., Ltd

Identity

Trade Name
Veress Needle EUDAMED
Unimicro FDA UDI
Generic Name
Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Device Name
Veress Needle EUDAMEDFDA UDI
Model / Reference
MND11500 EUDAMEDFDA UDI
Description
Veress needle FDA UDI

Identifiers

Primary DI / UDI-DI
06955797740025 EUDAMEDFDA UDI
Basic UDI-DI
B-06955797740025 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 EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Ireland 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
Sterilization Method
Ethylene Oxide FDA UDI

Veress Needle by Unimicro Medical Systems (shenzhen) Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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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 (3)

  • EUDAMED 6f9a7fb7-38d2-4b79-8315-a3a9f7759815 61 fields · synced Jul 31, 2026
  • FDA UDI f895543c-6458-4dab-8d92-33aa1351b4db 33 fields · synced May 30, 2026
  • FDA 510(k) K150068 1 fields · synced May 18, 2026