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Holding pipettes (MT-HD)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 95303Model Holding Pipette (MT-HD)
Identity
- Trade Name
- Holding pipettes (MT-HD) EUDAMEDKitazato Holding Micropipette FDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- Micro Tools EUDAMEDHolding Micropipette FDA UDI
- Model / Reference
- Holding Pipette (MT-HD) EUDAMED95303 EUDAMEDMT-HD-120-35 FDA UDI
- Description
- Holding Micropipette FDA UDI
Identifiers
- Catalog Number
- 95303 FDA UDI
- Primary DI / UDI-DI
- 04582231467914 EUDAMEDFDA UDI
- Basic UDI-DI
- 458223146MTTT EUDAMED
- FDA Product Code
- PUC FDA UDI
- EMDN Code
- U0802030103,U0802030105 EUDAMED
- GMDN Term
- Assisted reproduction microtool FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Holding pipettes (MT-HD) by Kitazato Corporation — Class IIa — 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 | 458223146MTTT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Kitazato Corporation
- EUDAMED SRN
- JP-MF-000018374
- Authorised Representative
- BIOMEDICAL SUPPLY, S.L. ES-AR-000014358
Sources (2)
- EUDAMED 4e8685d1-cdca-4717-9613-cdfe9f771498 61 fields · synced Jul 13, 2026
- FDA UDI b217b978-eb47-45c1-9980-46773c70c904 34 fields · synced May 30, 2026