Burg Pharma

by Jiangsu Caina Medical Co., Ltd.

Part of a family of 37 devices: see the family page

Ref 4311Model PP01 series

Burg Pharma (4311) is a Class IIa device made by Jiangsu Caina Medical Co., Ltd., registered in EUDAMED on 20 May 2025 (Basic UDI-DI 69715644600340ZU), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69715644600340ZU Basic UDI-DI 06971564462211UDI-DI	Date20 May 2025Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI 69715644600340ZU — open Devices and search for it

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name: Pre-Filled Syringe with Saline
Model / reference: PP01 series, 4311

Primary DI / UDI-DI: 06971564462211
Basic UDI-DI: 69715644600340ZU
EMDN code: A02010701 Prefilled syringes with sterile physiological solution

Device class: Class IIa
System or procedure pack: System which is a device in itself
EU registration type: Standard device
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000011217
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION.

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Properties

Supplied sterile

Other properties (13, all answered No)