Sterile Vascular Silicone Ties

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 10-1101

by Batrik Medical Manufacturing Inc.

Identity

Trade Name: Batrik Vascular Silicones Ties, X-Mini Blue FDA UDI
Generic Name: Surgical vessel loop FDA UDI
Device Name: Sterile Vascular Silicone Ties EUDAMED
"Vascular Silicone Ties, Radio Opaque, Sterile, Extra Mini-Blue, 0.040"" x 16"" / 0.1cm x 40 cm" FDA UDI
Model / Reference: 10-1101 EUDAMEDFDA UDI
Description: "Vascular Silicone Ties, Radio Opaque, Sterile, Extra Mini-Blue, 0.040"" x 16"" / 0.1cm x 40 cm" FDA UDI

Identifiers

Catalog Number: 10-1101 FDA UDI
Primary DI / UDI-DI: 00690521014084 EUDAMEDFDA UDI
Basic UDI-DI: 6905210VSTST100F8 EUDAMED
FDA Product Code: HCF FDA UDI
EMDN Code: C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Surgical vessel loop FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Market of Registration: Malta EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical bulldog clamp, single-use

Sterile Vascular Silicone Ties by Batrik Medical Manufacturing Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical bulldog clamp, single-use.

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BM-BID-I30C — BrosMed Medical Co., Ltd. · Class I
Scanlan® VASCU-STATT® approximator single-use bulldog clamp — SCANLAN INTERNATIONAL INC · Class I
BM-BID-I30P — BrosMed Medical Co., Ltd. · Class I
SELEPUMP® — KOSSEL MEDTECH (SUZHOU) CO., LTD. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	6905210VSTST100F8	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Batrik Medical Manufacturing Inc.
EUDAMED SRN: CA-MF-000007738
Authorised Representative: Advena Limited MT-AR-000000234

Sources (2)

EUDAMED 4e20ea19-7e71-406f-a512-80f8f6f2ae72 61 fields · synced Jul 9, 2026
FDA UDI 94b2006a-28f8-4e6c-bed1-1da37b9406bd 36 fields · synced May 30, 2026