Identity
- Trade Name
- ORAcollect Dx EUDAMEDFDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab FDA UDI
- Device Name
- ORAcollect (Swab based DNA & Dx Collection Device) EUDAMEDDNA Specimen Collection, Saliva FDA UDI
- Model / Reference
- OCD-100A EUDAMEDFDA UDI
- Description
- DNA Specimen Collection, Saliva FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000316 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627595B0200EX EUDAMED
- FDA Product Code
- OYJ FDA UDI
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
- GMDN Term
- Oral/upper respiratory tract specimen collection swab FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ORAcollect Dx by DNA Genotek Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0627595B0200EX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DNA Genotek Inc.
- EUDAMED SRN
- CA-MF-000003486
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED a5e77e7c-d701-405b-bce5-56668f9168bc 61 fields · synced Jul 9, 2026
- FDA UDI 60698651-346b-4865-ae1a-e65ebb8eea59 35 fields · synced May 30, 2026