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Multipurpose Handling Medium-Complete (MHM-C)
EUDAMEDFDA UDIClass III (EU MDR)
Ref 90166Model 90166-500mLModel 90166-12x12mLModel 90166-100mL
Identity
- Trade Name
- Multipurpose Handling Medium-Complete (MHM-C) EUDAMEDMultipurpose Handling Medium - Complete (MHM-C) with Gentamicin and HSA FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Multipurpose Handling Medium-Complete (MHM-C) EUDAMEDMHM-C is dual buffered solution (HEPES and MOPS). MHM-C contains human serum albumin (HSA) and the antibiotic Gentamicin Sulfate. FDA UDIMHM-C is dual buffered solution (HEPES and MOPS). MHM-C contains human serum albumin (HSA) and the antibiotic Gentamicin Sulfate. FDA UDI
- Model / Reference
- 90166-500mL EUDAMEDFDA UDI90166 EUDAMED90166-12x12mL EUDAMEDFDA UDI90166-100mL EUDAMEDFDA UDI
- Description
- MHM-C is dual buffered solution (HEPES and MOPS). MHM-C contains human serum albumin (HSA) and the antibiotic Gentamicin Sulfate. FDA UDIMHM-C is dual buffered solution (HEPES and MOPS). MHM-C contains human serum albumin (HSA) and the antibiotic Gentamicin Sulfate. FDA UDI
Identifiers
- Catalog Number
- 90166 FDA UDI
- Primary DI / UDI-DI
- 00810195240286 EUDAMEDFDA UDI00810195240262 EUDAMEDFDA UDI00810195240279 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240286 EUDAMEDB-00810195240262 EUDAMEDB-00810195240279 EUDAMED
- 510(k) Number
- K121128 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
Yes
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
Multipurpose Handling Medium-Complete (MHM-C) by Irvine Scientific, Llc — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00810195240286 | 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 (9)
- EUDAMED fc1373c8-c677-4fac-a66d-bd2aaaef2f6f 61 fields · synced Jul 31, 2026
- EUDAMED e0426796-72c4-4577-876c-98255b592a89 61 fields · synced May 17, 2026
- EUDAMED f176f410-c52d-4714-8e12-1d86216a9502 61 fields · synced May 19, 2026
- FDA UDI 6567a5e6-f3f0-4f4d-8ff3-75da8e642f9e 36 fields · synced May 30, 2026
- FDA UDI bc249f2b-068d-4b94-b6e0-bdb95532d0a1 36 fields · synced May 30, 2026
- FDA UDI 8aeae06f-99a3-4820-accd-4cadca76930e 36 fields · synced May 30, 2026
- EUDAMED 907a2735-e6fb-4ead-996c-39830d828dbb 61 fields · synced Jun 18, 2026
- EUDAMED 77de5fa4-151b-433c-ad2a-63118dd14e2b 61 fields · synced Jul 31, 2026
- EUDAMED 54206a3b-15bb-4353-a078-846c0b93724c 61 fields · synced Jul 31, 2026