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Continuous Single Culture (CSCM) with Gentamicin
EUDAMEDFDA UDIClass III (EU MDR)
Ref 90164Model 90164-60mL
Identity
- Trade Name
- Continuous Single Culture (CSCM) with Gentamicin EUDAMEDFDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Continuous Single Culture (CSCM) with Gentamicin EUDAMEDContinuous Single Culture (CSCM) medium optimized to be used in an uninterrupted culture system without dish change or medium renewal. The medium contains Gentamicin Sulfate. FDA UDI
- Model / Reference
- 90164-60mL EUDAMEDFDA UDI90164 EUDAMED
- Description
- Continuous Single Culture (CSCM) medium optimized to be used in an uninterrupted culture system without dish change or medium renewal. The medium contains Gentamicin Sulfate. FDA UDI
Identifiers
- Catalog Number
- 90164 FDA UDI
- Primary DI / UDI-DI
- 00810195240460 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240460 EUDAMED
- 510(k) Number
- K072609 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 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
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 (CSCM) 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-00810195240460 | 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 (3)
- EUDAMED 104a9e51-eb45-463d-b9a8-b34b5925e676 61 fields · synced Jul 20, 2026
- FDA UDI ed78abdc-2497-4def-9714-9fff04a81730 36 fields · synced May 30, 2026
- EUDAMED 60854eb6-b687-4892-9f80-701a2f4760a7 61 fields · synced Jul 20, 2026