← Back to catalogue

Cora

FDA UDI

Class II (US FDA UDI)

by Cora

Identity

Trade Name
Cora FDA UDI
Generic Name
Menstrual cup/disc, non-latex, reusable FDA UDI
Device Name
Cora Disc, DTC + Amazon FDA UDI
Model / Reference
10Disc-008 FDA UDI
Description
Cora Disc, DTC + Amazon FDA UDI

Identifiers

Primary DI / UDI-DI
X0037EZAVV FDA UDI
FDA Product Code
HHE FDA UDI
GMDN Term
Menstrual cup/disc, non-latex, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.5400 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Cora by Cora — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Cora

Sources (1)

  • FDA UDI 38c4f3c2-2e27-4513-b997-170ecaae19a6 34 fields · synced May 30, 2026