Identity
- Trade Name
- Cryotop US(R) FDA UDI
- Generic Name
- Assisted reproduction vitrification carrier FDA UDI
- Model / Reference
- Cryotop US(R) FDA UDI
Identifiers
- Catalog Number
- 81172 FDA UDI
- Primary DI / UDI-DI
- 04582231462902 FDA UDI
- 510(k) Number
- K153027 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- Assisted reproduction vitrification carrier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction vitrification carrier
Cryotop US(R) by Kitazato Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction vitrification carrier.
- S-CRYOLOCK (B) — BIOTECH INCORPORATED · Class II
- VitriGuard — Origio A/S · Class II
- Serological Pipette 1 mL — BIRR Biosciences BV · Class IIa
- Dry Incubator / EC6S-230MR — ASTEC CO.,Ltd · Class IIa
- CRYOPETTE — ORIGIO INC. · Class II
- Kryo 500 Series Controlled Rate Freezer — PLANER LIMITED · Class I
- VitriGuard — Origio A/S · Class II
- CRYOPETTE — ORIGIO INC. · Class II
Cleared under the same submission
K153027 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kitazato Corporation
Sources (2)
- FDA UDI f1f3b17d-2a75-49d0-b823-308a67ec23c6 34 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 28, 2026