Identity
- Trade Name
- Quick Thaw EUDAMEDQuickThaw® FDA UDI
- Generic Name
- Cryopreserved blood/tissue thawing unit FDA UDI
- Device Name
- Plasma Thawing System EUDAMEDFDA UDI
- Model / Reference
- DH4 EUDAMEDFDA UDIDH EUDAMED
- Description
- Plasma Thawing System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816394020643 EUDAMEDFDA UDI
- Basic UDI-DI
- 081639402TFR0036N EUDAMED
- Direct Marketing DI
- 00816394020643 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- Z121703 BLOOD AND BLOOD COMPONENTS THAWERS EUDAMED
- GMDN Term
- Cryopreserved blood/tissue thawing unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cryopreserved blood/tissue thawing unit
QuickThaw® by HELMER Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HELMER Inc.
Sources (2)
- FDA UDI 1c0258b0-400b-4b93-b173-54933102ee07 34 fields · synced Jul 26, 2026
- EUDAMED 22ba2c71-8d21-4935-9f47-0a3caff03264 61 fields · synced Jul 26, 2026