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Syringe, 10 mL

EUDAMEDFDA UDI

Class I (EU MDR)

Ref E01P3Model Syringe, 10 mL

by Front Line Medical Technologies Inc.

Identity

Trade Name
Syringe, 10 mL FDA UDI
Generic Name
General-purpose syringe, single-use FDA UDI
Device Name
Syringe, 10 mL EUDAMED
The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. FDA UDI
Model / Reference
Syringe, 10 mL EUDAMED
E01P3 EUDAMEDFDA UDI
Description
The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. FDA UDI

Identifiers

Catalog Number
E01P3 FDA UDI
Primary DI / UDI-DI
10628678061061 EUDAMEDFDA UDI
Basic UDI-DI
628678061002HL EUDAMED
510(k) Number
K201652 FDA UDI
FDA Product Code
MJN FDA UDI
EMDN Code
A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
GMDN Term
General-purpose syringe, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Market of Registration
Spain 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

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 10 Milliliter FDA UDI

Syringe, 10 mL by Front Line Medical Technologies Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Front Line Medical Technologies Inc.
EUDAMED SRN
CA-MF-000035504
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (2)

  • EUDAMED e4d0f4ae-c4e9-4543-a0aa-99fd56c581a9 61 fields · synced May 31, 2026
  • FDA UDI a6f97213-a079-4b62-935e-f1e688b6de58 36 fields · synced May 29, 2026