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Safety Blood Collection Set with Tube Holder

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref Safety Blood Collection Set with Tube Holder, 19cm tubing, 25G needleModel Sns-LH510(k) K230080

by Gemtier Medical (Shanghai) Inc.

Identity

Device Name
Safety Blood Collection Set with Tube Holder EUDAMED
Model / Reference
Sns-LH EUDAMED
Safety Blood Collection Set with Tube Holder, 19cm tubing, 25G needle EUDAMED

Identifiers

Primary DI / UDI-DI
16955356101301 EUDAMED
Basic UDI-DI
69553561SNSLH2P EUDAMED
Direct Marketing DI
16955356101301 EUDAMED
EMDN Code
A010199 NEEDLES FOR INFUSION AND COLLECTION - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Safety Blood Collection Set with Tube Holder by Gemtier Medical (Shanghai) Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Gemtier Medical (Shanghai) Inc.
EUDAMED SRN
CN-MF-000003835
FDA Applicant
Yangzhou Medline Industry, Co., Ltd.
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (3)

  • EUDAMED 5f0286ba-44cd-41b8-850a-10cdf138d92a 85 fields · synced Oct 6, 2026
  • EUDAMED 5f0286ba-44cd-41b8-850a-10cdf138d92a-1 61 fields · synced Jun 9, 2026
  • FDA 510(k) K230080 1 fields · synced May 18, 2026