Identity
- Trade Name
- Biotecno FDA UDI
- Generic Name
- Blood plasma freezer FDA UDI
- Device Name
- Biotecno Conservation Chamber BT-1100/1500l FDA UDI
- Model / Reference
- BT-1100/1500l FDA UDI
- Description
- Biotecno Conservation Chamber BT-1100/1500l FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07908823600038 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Blood plasma freezer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Blood plasma freezer
Biotecno by Biotecno Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biotecno Industria E Comercio Ltda
Sources (1)
- FDA UDI f3477ca6-3e03-47da-955e-91fb6cf0fd47 33 fields · synced May 30, 2026