Identity
- Trade Name
- AMSure® Pediatric Urine Collector EUDAMEDFDA UDI
- Generic Name
- Paediatric urine collection/analysis kit IVD FDA UDI
- Device Name
- Urine Bag EUDAMEDAMSure® Pediatric Urine Collector FDA UDI
- Model / Reference
- AS408 EUDAMED1 FDA UDI
- Description
- AMSure® Pediatric Urine Collector FDA UDI
Identifiers
- Catalog Number
- AS408 FDA UDI
- Primary DI / UDI-DI
- 10704411008040 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411008040 EUDAMED
- FDA Product Code
- EXI FDA UDI
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
- GMDN Term
- Paediatric urine collection/analysis kit IVD FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5250 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: Paediatric urine collection/analysis kit IVD
AMSure® Pediatric Urine Collector by Amsino International, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Paediatric urine collection/analysis kit IVD.
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 d5332347-0833-42d5-b726-ed1135429185 34 fields · synced Oct 6, 2026
- EUDAMED c3cc126b-1264-4f82-91cb-2f02be12daf3 61 fields · synced Jul 22, 2026