Identity
- Trade Name
- NidOil EUDAMEDNidacon FDA UDI
- Generic Name
- Spermatozoa/semen motility medium supplement FDA UDI
- Device Name
- NidOil EUDAMEDThe product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator FDA UDI
- Model / Reference
- NO-100 EUDAMEDNidOil™ FDA UDI
- Description
- The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator FDA UDI
Identifiers
- Catalog Number
- NO-100 FDA UDI
- Primary DI / UDI-DI
- 07350025610177 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350025610177 EUDAMED
- 510(k) Number
- K012123 FDA UDI
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- Spermatozoa/semen motility medium supplement FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Market of Registration
- Sweden 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
No
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
NidOil by Nidacon International Ab — 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-07350025610177 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Nidacon International AB
- EUDAMED SRN
- SE-MF-000001933
Sources (2)
- EUDAMED 05242ea2-8523-45d6-93c0-fa4d6ab31f53 61 fields · synced Jun 20, 2026
- FDA UDI 690ea9ea-2092-48e9-90f0-5ef7cb4f5b78 37 fields · synced May 30, 2026