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Sample Preservative Fluid

EUDAMEDFDA UDI

Class A (EU MDR)

Ref BSC82L1Model 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

by Hangzhou Bioer Technology Co., Ltd.

Identity

Trade Name
Sample Preservative Fluid EUDAMED
BIOER Sample Preservative Fluid FDA UDI
Generic Name
General specimen container IVD, additive/medium FDA UDI
Device Name
Sample Preservative Fluid EUDAMED
For 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 EUDAMED
BSC82L1 EUDAMEDFDA UDI
Description
For the detail information, please refer to the IFU. FDA UDI

Identifiers

Primary DI / UDI-DI
06973843226699 EUDAMED
06973843228242 FDA UDI
Basic UDI-DI
697384322BSC82HZ EUDAMED
Direct Marketing DI
06973843226699 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 EUDAMED
Class 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hangzhou Bioer Technology Co., Ltd.
EUDAMED SRN
CN-MF-000019512
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED d8774456-9eec-4b2e-94c2-8c78595a69da 61 fields · synced Jul 26, 2026
  • FDA UDI 5c38781d-285e-4676-a3ad-074a8cf8062a 33 fields · synced May 30, 2026