Identity
- Trade Name
- Micro pipette, plastic EDTA 1x100 EUDAMEDMicro pipette, plastic EDTA FDA UDI
- Generic Name
- Capillary blood transfer tube IVD, EDTA FDA UDI
- Device Name
- Boule Micropipettes EUDAMEDAccessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers. FDA UDI
- Model / Reference
- 1070039 EUDAMEDMicro pipette, plastic EDTA 1x100 FDA UDI
- Description
- Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers. FDA UDI
Identifiers
- Catalog Number
- 1070039 FDA UDI
- Primary DI / UDI-DI
- 07350040790687 EUDAMEDFDA UDI
- Basic UDI-DI
- 735004079A009YN EUDAMED
- FDA Product Code
- GIO FDA UDI
- EMDN Code
- W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMED
- GMDN Term
- Capillary blood transfer tube IVD, EDTA FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.6150 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Micro pipette, plastic EDTA 1x100 by Boule Medical AB — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 735004079A009YN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Boule Medical AB
- EUDAMED SRN
- SE-MF-000001911
Sources (2)
- EUDAMED 431e0767-8934-4064-8e76-0b748bceb58f 61 fields · synced Jul 30, 2026
- FDA UDI 3cf68b45-5c5f-4e2d-9bde-fdb6f3593d43 36 fields · synced May 30, 2026