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Dry Container

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 5312

by Richard-Allan Scientific LLC

Identity

Trade Name
Dry Container EUDAMED
Epredia FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
Dry Containers EUDAMED
The Dry Container portfolio is designed to provide the end-user with the flexibility of filling their own container with a specified fixative. These non-sterile containers are supplied unlabeled and unassembled. The Dry Containers do not expire, and storage temperature should be evaluated on an individual basis according to the reagent in which the container is filled. FDA UDI
Model / Reference
5312 EUDAMED
Dry Containers, Unassembled, Unlabelled Bulk Pack FDA UDI
Description
The Dry Container portfolio is designed to provide the end-user with the flexibility of filling their own container with a specified fixative. These non-sterile containers are supplied unlabeled and unassembled. The Dry Containers do not expire, and storage temperature should be evaluated on an individual basis according to the reagent in which the container is filled. FDA UDI

Identifiers

Catalog Number
5312 FDA UDI
Primary DI / UDI-DI
00673693078221 EUDAMEDFDA UDI
Basic UDI-DI
0673693RAS023RH EUDAMED
Unit of Use DI
00673693002752 EUDAMED
FDA Product Code
NNI FDA UDI
EMDN Code
W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER EUDAMED
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

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

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

Yes

FDA UDI

Category: General specimen container IVD, no additive/medium

Dry Container by Richard-Allan Scientific LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
US-MF-000008261
Authorised Representative
Epredia Netherlands B.V. NL-AR-000001488

Sources (2)

  • EUDAMED 14a9488d-867f-4cac-9e86-e014d4354851 61 fields · synced Jun 19, 2026
  • FDA UDI dd7049b0-9401-4c63-844d-3172f744851d 34 fields · synced May 30, 2026