Vacu-Tec Double Label
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- VACU-TEC DOUBLE LABEL EUDAMEDFDA UDI
- Generic Name
- Evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
- Device Name
- VACU-TEC S.C. EUDAMED
- Model / Reference
- 10200/W EUDAMEDFDA UDIESRTUBES EUDAMED
Identifiers
- Catalog Number
- 10200/W FDA UDI
- Primary DI / UDI-DI
- 08033891320546 EUDAMEDFDA UDI
- Basic UDI-DI
- 803389132ESRTUBES00JL EUDAMED
- FDA Product Code
- GHC FDA UDI
- EMDN Code
- W01030107 ERYTHROCYTE SEDIMENTATION RATE (ESR) TEST EUDAMED
- GMDN Term
- Evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.6700 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Evacuated erythrocyte sedimentation rate (ESR) tube IVD
Vacu-Tec Double Label by Diesse Diagnostica Senese Spa — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated erythrocyte sedimentation rate (ESR) tube IVD.
- Excyte® ESR Vacuum Tubes, Carton — ELITECHGROUP INC. · Class I
- Monosed® ESR Vacuum Tubes — ELITECHGROUP INC. · Class I
- Excyte® ESR Vacuum Tube, Carton — ELITECHGROUP INC. · Class I
- Monosed® ESR Vacuum Tubes, Carton — ELITECHGROUP INC. · Class I
- Excyte® ESR Non-Vacuum Tubes, Carton — ELITECHGROUP INC. · Class I
- BD Vacutainer® ESR Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- Excyte® ESR Vacuum Tube, Carton — ELITECHGROUP INC. · Class I
- BD Seditainer™ 0.105M 1.25ml Buffered Sodium Citrate Blood Collection Tubes — Becton, Dickinson U.K. Limited · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diesse Diagnostica Senese Spa
Sources (2)
- FDA UDI 220b4fc9-bc36-4352-b796-fd56c1028e0e 33 fields · synced Jun 19, 2026
- EUDAMED 0d921654-0644-4f79-a2e5-282becf91f05 61 fields · synced Jun 19, 2026