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Continuous Single Culture - NX Complete (CSCM-NXC)
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 90168Model 90168-2x20mL510(k) K170602Model 90168-60mL
Identity
- Trade Name
- Continuous Single Culture - NX Complete (CSCM-NXC) EUDAMEDContinuous Single Culture - NX Complete (CSCM-NXC) with Gentamicin and HSA FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Continuous Single Culture - NX Complete (CSCM-NXC) EUDAMEDCSCM-NXC is a single step culture medium optimized to be used in an uninterrupted culture system, without dish change or medium renewal. CSCM-NXC contains human serum albumin (HSA) and the antibiotic Gentamicin Sulphate. FDA UDI
- Model / Reference
- 90168-2x20mL EUDAMEDFDA UDI90168 EUDAMED90168-60mL EUDAMEDFDA UDI
- Description
- CSCM-NXC is a single step culture medium optimized to be used in an uninterrupted culture system, without dish change or medium renewal. CSCM-NXC contains human serum albumin (HSA) and the antibiotic Gentamicin Sulphate. FDA UDI
Identifiers
- Catalog Number
- 90168 FDA UDI
- Primary DI / UDI-DI
- 00810195240491 EUDAMEDFDA UDI00810195240507 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240491 EUDAMEDB-00810195240507 EUDAMED
- 510(k) Number
- K170602 FDA UDI
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
Yes
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Continuous Single Culture - NX Complete (CSCM-NXC) by Irvine Scientific, Llc — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170602 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00810195240491 | Class III | Active |
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Manufacturer
- Manufacturer
- Irvine Scientific, LLC.
- EUDAMED SRN
- US-MF-000007514
- FDA Applicant
- Irvine Scientific Sales Co., Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED af9fee6e-3c56-4fd3-acda-15a964876bf9 85 fields · synced Jun 20, 2026
- EUDAMED 4e8e0005-acea-463a-88b1-391f78f0efe2 61 fields · synced May 19, 2026
- FDA UDI 87300a92-d167-48be-9f45-e22a6c8dc0fa 36 fields · synced May 30, 2026
- FDA UDI 8c83ecaf-7dd2-431d-a823-df54d788dbdc 36 fields · synced May 30, 2026
- EUDAMED 9f8728c2-540d-4083-8131-70f61659fc67 61 fields · synced Jun 18, 2026
- EUDAMED 91dc6ced-18f1-4451-9d61-4644000c844f 61 fields · synced Jun 20, 2026
- FDA 510(k) K170602 1 fields · synced May 18, 2026