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23andMe Personal Genome Service
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref Product Segment = Consumer
Identity
- Trade Name
- 23andMe Personal Genome Service EUDAMED23andMe, Inc. Personal Genome Service®(PGS) FDA UDI
- Generic Name
- Human genomic analysis interpretive software FDA UDI
- Device Name
- 23andMe PGS Coregen Software EUDAMED23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related) FDA UDI23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update FDA UDI23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, SLCO1B1 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight FDA UDI
- Model / Reference
- Product Segment = Consumer EUDAMEDYouDot FDA UDI
- Description
- 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related) FDA UDI23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update FDA UDI23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, SLCO1B1 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859462006385 EUDAMEDFDA UDI00859462006392 EUDAMEDFDA UDI00859462006408 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00859462006385 EUDAMEDB-00859462006408 EUDAMEDB-00859462006392 EUDAMED
- 510(k) Number
- DEN140044 FDA UDIDEN160026 FDA UDIDEN170046 FDA UDIDEN180028 FDA UDIK182784 FDA UDIK193492 FDA UDI
- FDA Product Code
- PTA FDA UDIPKB FDA UDIQDJ FDA UDIQAZ FDA UDI
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
- GMDN Term
- Human genomic analysis interpretive software FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5950 FDA UDI866.5940 FDA UDI862.3364 FDA UDI866.6090 FDA UDI
- Special Device Type
- -1202 EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
23andMe Personal Genome Service by 23andMe Genomics LLC — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00859462006385 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- 23andMe Genomics LLC
- EUDAMED SRN
- US-MF-000022267
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (6)
- EUDAMED 516d2ba2-21a5-4d04-ba66-59b262b0e8e8 61 fields · synced Jul 30, 2026
- FDA UDI 589f8304-cd6c-4dcd-a3f7-f68558619b0f 35 fields · synced May 30, 2026
- FDA UDI fcb2e86e-3d8b-4403-b478-4f5fe43d42ba 35 fields · synced May 30, 2026
- FDA UDI ee065a59-c87d-41d5-a94e-ced9bfdd52b3 35 fields · synced May 30, 2026
- EUDAMED 19423dc8-63aa-4648-865c-7742ddd8e8c1 61 fields · synced Jul 11, 2026
- EUDAMED 1c608a03-84b7-4a66-bbfc-284cfa0e6494 61 fields · synced Jul 30, 2026