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Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing）
EUDAMEDClass A (EU MDR)
Ref S000405Model FCM 150cycles,FCM 300cycles,FCH-D SE075-D,FCH 300cycles,FCH 150cycles,FCM-D SE075-D,GenoLab FCM 150cycles,GenoLab FCM 300cycles,GenoLab FCM-D SE075-D,GenoLab FCH 150cycles,GenoLab FCH 300cycles,GenoLab FCH-D SE075-DRef S000126Model FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-DRef S000068Ref S000067Ref S000065Ref S000401Ref S000403Ref S000404Ref S000136Ref S000141Ref S000121Ref S000066
Identity
- Trade Name
- Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） EUDAMED
- Device Name
- Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） EUDAMED
- Model / Reference
- FCM 150cycles,FCM 300cycles,FCH-D SE075-D,FCH 300cycles,FCH 150cycles,FCM-D SE075-D,GenoLab FCM 150cycles,GenoLab FCM 300cycles,GenoLab FCM-D SE075-D,GenoLab FCH 150cycles,GenoLab FCH 300cycles,GenoLab FCH-D SE075-D EUDAMEDS000405 EUDAMEDFASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-D EUDAMEDS000126 EUDAMEDS000068 EUDAMEDS000067 EUDAMEDS000065 EUDAMEDS000401 EUDAMEDS000403 EUDAMEDS000404 EUDAMEDS000136 EUDAMEDS000141 EUDAMEDS000121 EUDAMEDS000066 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583520 EUDAMED06974968583353 EUDAMED06974968583087 EUDAMED06974968583070 EUDAMED06974968583056 EUDAMED06974968583483 EUDAMED06974968583506 EUDAMED06974968583513 EUDAMED06974968583377 EUDAMED06974968583384 EUDAMED06974968583346 EUDAMED06974968583063 EUDAMED
- Basic UDI-DI
- 697496858R-Kit2U EUDAMED697496858FASTASeq-Kit2W EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） by GeneMind Biosciences Co., Ltd. — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697496858R-Kit2U | Class A | Active |
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Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (12)
- EUDAMED 0c5d13e9-d2b7-4b73-9e33-702b9dd35b64 61 fields · synced Aug 1, 2026
- EUDAMED f9c7a263-b6f5-4f9f-852f-1716f931bfa0 61 fields · synced May 17, 2026
- EUDAMED 20de6e77-7946-4349-823b-d311be10bb35 61 fields · synced May 17, 2026
- EUDAMED babc5454-b2c2-4711-a4a2-1176499d6c4e 61 fields · synced May 17, 2026
- EUDAMED df6c1559-d2a7-489a-8155-02369c0b5f21 61 fields · synced May 17, 2026
- EUDAMED 6636007e-e175-430a-956d-5e0482489c31 61 fields · synced May 18, 2026
- EUDAMED 1e374278-144e-4136-a5b7-a3cfd4310aa0 61 fields · synced May 18, 2026
- EUDAMED d5d873e2-83d9-46d1-b3ea-8d715cbc5de7 61 fields · synced May 18, 2026
- EUDAMED 363a7590-1b0a-4ef0-a9f0-a92f4ae025a0 61 fields · synced May 18, 2026
- EUDAMED 836a9360-291d-452e-ae9b-baddcf794bc9 61 fields · synced May 18, 2026
- EUDAMED 39bc1a63-221a-4c51-bf51-77c849c06b90 61 fields · synced May 19, 2026
- EUDAMED e35eea3f-d075-4f9b-9c8c-3772974e7a5b 61 fields · synced May 19, 2026