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Medical Centrifuge
EUDAMEDFDA UDIClass I (EU MDR)
Ref BS014Ref Mini-5SRef Mini-7Ref BKC-TL4PRef BKC-TL5PRef Mini-5Ref Mini-10SRef BKC-VL8RDRef BKC-TL3MPRef BKC-TH16RBRef BKC-TL4CeRef BKC-TH21RSRef Mini-12Ref BKC-TL6CRRef BKC-TL6B
Identity
- Trade Name
- Medical Centrifuge EUDAMEDBIOBASE FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- Medical Centrifuge EUDAMED
- Model / Reference
- BS014 EUDAMEDMini-5S EUDAMEDMini-7 EUDAMEDBKC-TL4P EUDAMEDBKC-TL5P EUDAMEDMini-5 EUDAMEDMini-10S EUDAMEDBKC-VL8RD EUDAMEDBKC-TL3MP EUDAMEDBKC-TH16RB EUDAMEDBKC-TL4Ce EUDAMEDBKC-TH21RS EUDAMEDMini-12 EUDAMEDBKC-TL6CR EUDAMEDBKC-TL6B EUDAMEDBKC-AU4A FDA UDIBKC-TH16MB FDA UDIBKC-TL4B FDA UDIBKC-TL5C FDA UDIBKC-TL4G FDA UDIBKC-TL4Cyto FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936895301295 EUDAMEDFDA UDI06936895301301 EUDAMEDFDA UDI06936895301257 EUDAMEDFDA UDI06936895301226 EUDAMEDFDA UDI06936895301288 EUDAMEDFDA UDI06936895301233 EUDAMEDFDA UDI06936895303244 EUDAMED06936895303213 EUDAMED06936895303381 EUDAMED06936895303398 EUDAMED06936895303206 EUDAMED06936895303282 EUDAMED06936895303176 EUDAMED06936895303190 EUDAMED06936895303145 EUDAMED06936895303060 EUDAMED06936895302827 EUDAMED06936895303237 EUDAMED06936895303169 EUDAMED06936895302797 EUDAMED
- Basic UDI-DI
- 6936895BS0142B EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2050 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose centrifuge IVD
Medical Centrifuge by Biobase Biodustry(Shandong) Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose centrifuge IVD.
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- 406 — GYROZEN · Class A
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6936895BS0142B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (31)
- EUDAMED 1826acbd-8d06-414a-a520-a0b3cf0a4381 61 fields · synced Oct 6, 2026
- EUDAMED 492622e4-e8d8-40be-ab16-15e5facb3258 61 fields · synced May 16, 2026
- EUDAMED 8bc9142c-6128-4130-9e35-dfcd42d81ed2 61 fields · synced May 17, 2026
- EUDAMED 581001bb-c61a-49d0-a8e4-13e95dbeab0d 61 fields · synced May 19, 2026
- EUDAMED 0f0fa896-cd12-49fe-9b3e-5bf98d16cd99 61 fields · synced May 19, 2026
- EUDAMED 6a8bbcda-e422-4c0a-8948-dc89cd4d4c33 61 fields · synced May 19, 2026
- FDA UDI 5c5ef8ac-f2a8-4f00-b729-b0f348f43f23 32 fields · synced May 29, 2026
- FDA UDI c6f5dc8a-7d82-404e-8d99-5240cc5006e4 32 fields · synced May 30, 2026
- FDA UDI 878bff58-df5f-49e9-b451-3283dd36a38e 32 fields · synced May 30, 2026
- FDA UDI 44c12060-a7cd-42fb-83ec-6ffb34c74631 32 fields · synced May 30, 2026
- FDA UDI 108fee5e-1ee6-49af-9f72-cf2fad3f4b46 32 fields · synced May 30, 2026
- FDA UDI 26bde103-d205-4735-90f3-c78ef31c748a 32 fields · synced May 30, 2026
- EUDAMED c7f765f1-61e7-4e98-b224-9114cc39c3dc 61 fields · synced Jul 8, 2026
- EUDAMED 20d951f3-0464-4399-bc73-e9477e8450c7 61 fields · synced Jul 9, 2026
- EUDAMED ad86756e-2eb2-48fe-8242-339e08e0f3d5 61 fields · synced Jul 9, 2026
- EUDAMED a7631524-f144-4433-91e8-de350e2553b7 61 fields · synced Jul 10, 2026
- EUDAMED 293f8473-c298-4e71-9646-6ece638755be 61 fields · synced Jul 10, 2026
- EUDAMED a3d09280-10c4-48df-bcf7-0122b4f75070 61 fields · synced Jul 10, 2026
- EUDAMED 1b241dca-a4f2-40af-bccf-1efcb67221a7 61 fields · synced Jul 10, 2026
- EUDAMED dce315a1-bbd1-4c93-ac6e-6a760951f3dc 61 fields · synced Jul 11, 2026
- EUDAMED 341b81bd-c640-4ce0-b7cc-e8d625a44317 61 fields · synced Jul 12, 2026
- EUDAMED e72d3405-92bf-4af6-8c7c-db6aaeb067a6 61 fields · synced Jul 13, 2026
- EUDAMED a1212f13-066d-44ec-abfb-e588d84c1d69 61 fields · synced Jul 13, 2026
- EUDAMED 047e1dd1-9da3-4ab5-9a38-d679845f7df8 61 fields · synced Jul 17, 2026
- EUDAMED 9b13b257-143b-4317-bdd2-87ce3a6b9249 61 fields · synced Jul 20, 2026
- EUDAMED 4379c349-0c23-46b1-ad3d-4eb7e3ed8fbc 61 fields · synced Jul 21, 2026
- EUDAMED 880b1854-2872-4a46-a827-e7dd467378eb 61 fields · synced Jul 24, 2026
- EUDAMED 00103ae2-8687-4672-9c7e-589e069d9d6e 61 fields · synced Jul 30, 2026
- EUDAMED 169c110e-e38f-4c5b-a5fc-8928a3a22adc 61 fields · synced Jul 30, 2026
- EUDAMED 57bd2483-e37b-4c45-81ac-9ba88132b1ed 61 fields · synced Jul 30, 2026
- EUDAMED d0aa4398-5646-49d2-b84e-ba26fab9284e 61 fields · synced Aug 3, 2026