Superfirt

EUDAMED

Class A (EU MDR)

Ref 4X5”Model 2X2”,2X3”,2X4”,2X10”,2X12”,2X20”, 3X3”, 3X4”, 3X5”,3X12”,3X20”,4X4”,4X5”,4X6”,4X7”,4X8”,4X10”, 5X5”,5X6”, 5X7”,5X8”, 5X10”, 6X4”,6X6”,6X8”, 6X9”, 6X10”,6X12”,8X8”,8X10”,8X12”, etc.

by Nanjing Superfit I & E Co., Ltd.

Identity

Trade Name: Superfirt EUDAMED
Device Name: Specimen Bag EUDAMED
Model / Reference: 2X2”,2X3”,2X4”,2X10”,2X12”,2X20”, 3X3”, 3X4”, 3X5”,3X12”,3X20”,4X4”,4X5”,4X6”,4X7”,4X8”,4X10”, 5X5”,5X6”, 5X7”,5X8”, 5X10”, 6X4”,6X6”,6X8”, 6X9”, 6X10”,6X12”,8X8”,8X10”,8X12”, etc. EUDAMED
4X5” EUDAMED

Identifiers

Primary DI / UDI-DI: 06976400132655 EUDAMED
Basic UDI-DI: 697640013SPB02GS EUDAMED
EMDN Code: W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Superfirt by Nanjing Superfit I & E Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	697640013SPB02GS	Class A	Active

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Manufacturer

Manufacturer: Nanjing Superfit I & E Co., Ltd.
EUDAMED SRN: CN-MF-000040037
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (1)

EUDAMED fadfef0e-290c-41f1-a6c7-98cb160b9ea1 61 fields · synced Jun 18, 2026