Identity
- Trade Name
- Dry Container EUDAMEDEpredia FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- Dry Containers EUDAMEDThe 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 EUDAMEDDry 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 EUDAMEDClass 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
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
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0673693RAS023RH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Richard-Allan Scientific LLC
- 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