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Sample Preservative Fluid
EUDAMEDFDA UDIClass A (EU MDR)
Ref BSC82X1-C2Model BSC82S1, BSC82M1, BSC82L1, BSC82N1, BSC82X1-A, BSC82X1-B, BSC82N1-1, BSC82X1-A1, BSC82X1-B1, BSC82X1-C1, BSC82X1-E1, BSC82N1-2, BSC82X1-A2, BSC82X1-B2, BSC82X1-C2, BSC82X1-E2Ref BSC82X1-E1
Identity
- Trade Name
- Sample Preservative Fluid EUDAMEDBIOER Sample Preservative Fluid FDA UDI
- Generic Name
- General specimen container IVD, additive/medium FDA UDI
- Device Name
- Sample Preservative Fluid EUDAMEDFor the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- BSC82S1, BSC82M1, BSC82L1, BSC82N1, BSC82X1-A, BSC82X1-B, BSC82N1-1, BSC82X1-A1, BSC82X1-B1, BSC82X1-C1, BSC82X1-E1, BSC82N1-2, BSC82X1-A2, BSC82X1-B2, BSC82X1-C2, BSC82X1-E2 EUDAMEDBSC82X1-C2 EUDAMEDFDA UDIBSC82X1-E1 EUDAMED
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843226576 EUDAMED06973843226613 EUDAMED06973843228211 FDA UDI
- Basic UDI-DI
- 697384322BSC82HZ EUDAMED
- Direct Marketing DI
- 06973843226576 EUDAMED06973843226613 EUDAMED
- FDA Product Code
- NNK FDA UDI
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sample Preservative Fluid by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697384322BSC82HZ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 4235f725-93f3-419a-a89a-c6c3f45bb69f 61 fields · synced Jul 30, 2026
- EUDAMED eb190e37-3bde-4329-b7c8-32de5b6afa97 61 fields · synced May 19, 2026
- FDA UDI 661a5dbb-330c-4a46-8493-d2bee1b92cdd 33 fields · synced May 29, 2026