Identity
- Trade Name
- AMSure® Specimen Cup EUDAMEDFDA UDI
- Generic Name
- Sputum specimen container IVD FDA UDI
- Device Name
- Specimen Container EUDAMEDAMSure® Specimen Cup CONTENTS: 4 oz Graduated Cup with Screw Cap FDA UDI
- Model / Reference
- AS345 EUDAMED1 FDA UDI
- Description
- AMSure® Specimen Cup CONTENTS: 4 oz Graduated Cup with Screw Cap FDA UDI
Identifiers
- Catalog Number
- AS345 FDA UDI
- Primary DI / UDI-DI
- 10704411008415 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411008415 EUDAMED
- FDA Product Code
- NNI FDA UDI
- EMDN Code
- W05010203 URINE COLLECTION, CONTAINERS EUDAMED
- GMDN Term
- Sputum specimen container IVD FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sputum specimen container IVD
AMSure® Specimen Cup by Amsino International, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI d913a6fc-a79d-4b7e-989c-ae7faa845562 34 fields · synced Jul 9, 2026
- EUDAMED 3fa24b96-b6ab-49aa-8f05-2f23aa8e382e 61 fields · synced Jul 9, 2026