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ALLTM Set
EUDAMEDClass IVD General (EU MDR)
Ref T5509Model ATB 4Ref T5503Model ATB 1Ref T5589Model ATB 8Ref T5004Model ATS 2Ref T5018Model ATS 1Ref T5019Ref T5504Model ATB 2Ref T5588Model ATB 7Ref T5003Ref 08800069150096Model ATS 4
Identity
- Trade Name
- ALLTM Set EUDAMED
- Model / Reference
- ATB 4 EUDAMEDT5509 EUDAMEDATB 1 EUDAMEDT5503 EUDAMEDATB 8 EUDAMEDT5589 EUDAMEDATS 2 EUDAMEDT5004 EUDAMEDATS 1 EUDAMEDT5018 EUDAMEDT5019 EUDAMEDATB 2 EUDAMEDT5504 EUDAMEDATB 7 EUDAMEDT5588 EUDAMEDT5003 EUDAMEDATS 4 EUDAMED08800069150096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069155091 EUDAMED08800069155039 EUDAMED08800069155893 EUDAMED08800069150041 EUDAMED08800069150188 EUDAMED08800069150195 EUDAMED08800069155046 EUDAMED08800069155886 EUDAMED08800069150034 EUDAMED08800069150096 EUDAMED
- Basic UDI-DI
- B-08800069155091 EUDAMEDB-08800069155039 EUDAMEDB-08800069155893 EUDAMEDB-08800069150041 EUDAMEDB-08800069150188 EUDAMEDB-08800069150195 EUDAMEDB-08800069155046 EUDAMEDB-08800069155886 EUDAMEDB-08800069150034 EUDAMEDB-08800069150096 EUDAMED
- EMDN Code
- A1102,W0104010203 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
ALLTM Set by SG BioScience Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08800069155091 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- SG BioScience Inc.
- EUDAMED SRN
- KR-MF-000009362
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (10)
- EUDAMED 7a9b5cb8-fc75-4232-ab63-d1af5de54c70 61 fields · synced Aug 4, 2026
- EUDAMED 3e2ed0ad-8247-4ed9-beb5-0392ac7a87c1 61 fields · synced May 16, 2026
- EUDAMED 88f90c5e-a9e3-4805-8c64-58b5e8832511 61 fields · synced May 17, 2026
- EUDAMED c4db6e1b-8a6b-4afb-b75a-3968b9ff2b33 61 fields · synced May 17, 2026
- EUDAMED 71eebc37-08c6-4d0a-94b5-32bb62fee887 61 fields · synced May 17, 2026
- EUDAMED 4edf6fde-4e34-41e8-bb1e-5c3c182949e0 61 fields · synced May 17, 2026
- EUDAMED afa11d35-2677-416a-8cca-9f4b578405f4 61 fields · synced May 17, 2026
- EUDAMED 15cc9d1f-f95b-49a5-8a66-21c298016b9a 61 fields · synced May 18, 2026
- EUDAMED 8a8d1ee3-964c-40eb-b3ce-14ee1ce8a63b 61 fields · synced May 19, 2026
- EUDAMED 23c19225-480a-47bf-93b0-84ffea11da3d 61 fields · synced May 19, 2026