Identity
- Trade Name
- Embryo Grid / AID-0125M EUDAMEDEmbryo Grid FDA UDI
- Generic Name
- Assisted reproduction procedure dish FDA UDI
- Device Name
- Embryo Grid EUDAMED
- Model / Reference
- AID-0125M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580647510033 EUDAMEDFDA UDI
- Basic UDI-DI
- 458064751A002DXZ EUDAMED
- Unit of Use DI
- 14580647510030 EUDAMED
- FDA Product Code
- PUD FDA UDI
- EMDN Code
- U080206 CULTURE PLATES FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- Assisted reproduction procedure dish FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Embryo Grid / AID-0125M by ASTEC CO., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458064751A002DXZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ASTEC CO., Ltd
- EUDAMED SRN
- JP-MF-000020597
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 37364e85-0d8f-49e3-a989-df6aa2342d45 61 fields · synced Jul 27, 2026
- FDA UDI c331d01f-f9d3-4a55-8150-dc4a2456d125 32 fields · synced May 30, 2026