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RIDA® CCD-Inhibitor

EUDAMEDFDA UDI

Class A (EU MDR)

Ref ZA0601

by R-Biopharm AG

Identity

Trade Name
RIDA® CCD-Inhibitor FDA UDI
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
Device Name
RIDA® CCD-Inhibitor EUDAMED
The RIDA® CCD-Inhibitor is an accessory for use in in vitro diagnostics for the inhibition of anti-CCD IgE in human serum and plasma. FDA UDI
Model / Reference
ZA0601 EUDAMEDFDA UDI
Description
The RIDA® CCD-Inhibitor is an accessory for use in in vitro diagnostics for the inhibition of anti-CCD IgE in human serum and plasma. FDA UDI

Identifiers

Primary DI / UDI-DI
04049095260049 EUDAMEDFDA UDI
Basic UDI-DI
4049095ZA06010000JB EUDAMED
FDA Product Code
DHL FDA UDI
EMDN Code
W01010299 SUBSTRATES - OTHER EUDAMED
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
866.4100 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

RIDA® CCD-Inhibitor by R-Biopharm AG — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
R-Biopharm AG
EUDAMED SRN
DE-MF-000007993

Sources (2)

  • EUDAMED b4981d4d-1456-4355-b0cd-eb24bac58cab 61 fields · synced Oct 5, 2026
  • FDA UDI 5c61c15e-3561-4bcb-a1f4-8a3ddfc40f06 33 fields · synced May 29, 2026