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Continuous Single Culture - NX (CSCM-NX) with Gentamicin
EUDAMEDFDA UDIClass III (EU MDR)
Ref 90167Model 90167-60mL
Identity
- Trade Name
- Continuous Single Culture - NX (CSCM-NX) with Gentamicin EUDAMEDFDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Continuous Single Culture - NX (CSCM-NX) with Gentamicin EUDAMEDCSCM-NX is a single step culture medium optimized to be used in an uninterrupted culture system, without dish change or medium renewal. The medium contains the antibiotic Gentamicin Sulphate. FDA UDI
- Model / Reference
- 90167-60mL EUDAMEDFDA UDI90167 EUDAMED
- Description
- CSCM-NX is a single step culture medium optimized to be used in an uninterrupted culture system, without dish change or medium renewal. The medium contains the antibiotic Gentamicin Sulphate. FDA UDI
Identifiers
- Catalog Number
- 90167 FDA UDI
- Primary DI / UDI-DI
- 00810195240484 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240484 EUDAMED
- 510(k) Number
- K170681 FDA UDI
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U08020503 MATERIALS/CULTURE MEDIA 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 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
No
EUDAMED
Human Tissues
No
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 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 (CSCM-NX) with Gentamicin by Irvine Scientific, Llc — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810195240484 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Irvine Scientific, LLC.
- EUDAMED SRN
- US-MF-000007514
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 19f3e83b-40ad-4e78-8f82-48b606654533 61 fields · synced Jun 18, 2026
- FDA UDI 46c15c33-088e-4af5-a91c-7fb822709709 36 fields · synced May 30, 2026