← Back to catalogue

Syringes

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref RF-T15

by OriGen Biomedical Inc.

Identity

Trade Name
Syringes EUDAMED
6ml Syringe to SCD Tube Accessory Set FDA UDI
Generic Name
Blood transfer set FDA UDI
Device Name
RF-T15 EUDAMED
6ml syringe on a female luer with 15cm sealed SCD tubing FDA UDI
Model / Reference
RF-T15 EUDAMEDFDA UDI
Description
6ml syringe on a female luer with 15cm sealed SCD tubing FDA UDI

Identifiers

Primary DI / UDI-DI
20816203020202 EUDAMED
10816203020205 FDA UDI
Basic UDI-DI
B-20816203020202 EUDAMED
FDA Product Code
KJG FDA UDI
EMDN Code
B0180 BLOOD BAGS AND KITS - ACCESSORIES EUDAMED
GMDN Term
Blood transfer set FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
864.3010 FDA UDI
Market of Registration
Austria 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Syringes by OriGen Biomedical, Inc. — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OriGen Biomedical Inc.
EUDAMED SRN
US-MF-000018098
Authorised Representative
Advena Limited MT-AR-000000234

Sources (2)

  • EUDAMED e41ef388-c5ba-4772-8967-6f6217ee1202 61 fields · synced May 31, 2026
  • FDA UDI 6f10ac77-26f3-413d-8982-c245029178da 34 fields · synced May 24, 2026