Identity
- Trade Name
- LBM CABroth EUDAMEDFDA UDI
- Generic Name
- General specimen container IVD, additive/medium FDA UDI
- Device Name
- CABroth EUDAMED
- Model / Reference
- 4U161N EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 4U161N FDA UDI
- Primary DI / UDI-DI
- 08053326011771 EUDAMED38053326011772 FDA UDI
- Basic UDI-DI
- 80533260CD0600AM0049J EUDAMED
- FDA Product Code
- JSD FDA UDI
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
- GMDN Term
- General specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen container IVD, additive/medium
LBM CABroth by Copan Italia Spa — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General specimen container IVD, additive/medium.
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- Aero-Med — AERO-MED LLC · Class I
- BIOER Viral Transport Medium — Hangzhou Bioer Technology Co., Ltd. · Class I
- BIOER Viral Transport Medium — Hangzhou Bioer Technology Co., Ltd. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- ERPeak — CooperSurgical, Inc. · Class I
- Color Urine Collection Kit — COLOR DIAGNOSTICS, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Copan Italia Spa
Sources (2)
- FDA UDI 44b5cd73-24f0-418f-9377-7f8959b79aaf 33 fields · synced Jul 16, 2026
- EUDAMED 467681a4-1151-4f14-a93b-e39cb23e4f5a 61 fields · synced Jul 16, 2026