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Borg Decloaker, RTU
EUDAMEDFDA UDIClass A (EU MDR)
Ref BD1000G1 Model Borg Decloaker, RTU
Identity
- Trade Name
- Borg Decloaker, RTU EUDAMEDBorg Decloaker RTU FDA UDI
- Generic Name
- Immunohistochemistry antigen retrieval reagent IVD FDA UDI
- Device Name
- Borg Decloaker, RTU EUDAMEDAlternate name : Borg Decloaker, RTU FDA UDI
- Model / Reference
- Borg Decloaker, RTU EUDAMEDBD1000G1 EUDAMEDFDA UDI
- Description
- Alternate name : Borg Decloaker, RTU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627014191 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BAGRETFS EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry antigen retrieval reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Sweden 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Borg Decloaker, RTU by Biocare Medical — 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 | 08476270BAGRETFS | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical
- EUDAMED SRN
- US-MF-000034581
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e315c805-a47a-46a4-be12-6ec090ec055e 61 fields · synced May 30, 2026
- FDA UDI e6df4253-3d26-4078-877c-05f265bd6ca5 34 fields · synced May 30, 2026