Identity
- Trade Name
- Biopsy Pipette EUDAMEDFDA UDI
- Generic Name
- User-induced micropipette FDA UDI
- Device Name
- Micromanipulation Pipettes EUDAMED
- Model / Reference
- 15117 EUDAMEDFDA UDI15603 EUDAMEDFDA UDI15122 EUDAMEDFDA UDI15150 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350025916283 EUDAMEDFDA UDI17350025916344 EUDAMEDFDA UDI17350025916337 EUDAMEDFDA UDI17350025916528 FDA UDI
- Basic UDI-DI
- 735002591ACADG EUDAMED
- FDA Product Code
- PUC FDA UDI
- EMDN Code
- U0802030101 BIOPSY PIPETTES FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- User-induced micropipette FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Category: User-induced micropipette
Biopsy Pipette by Vitrolife Sweden AB — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as User-induced micropipette.
- SFG Holding pipettes — SPECTRUM FERTILITY GROUP INC. · Class II
- SFG Denuding pipettes — SPECTRUM FERTILITY GROUP INC. · Class II
- ICSI Pipette — Vitrolife AB · Class II
- ICSI Pipette — Vitrolife AB · Class II
- Hatching Pipette — Vitrolife AB · Class II
- ICSI Pipette — Vitrolife AB · Class II
- Hatching Pipette — Vitrolife AB · Class II
- Holding Pipette — Vitrolife AB · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (7)
- FDA UDI b56bd653-2112-4ba4-b117-70429ac79668 32 fields · synced Jul 8, 2026
- FDA UDI fc12fe0f-2ad0-4d94-b68b-f7c917c26ee7 32 fields · synced May 29, 2026
- FDA UDI 0e713fff-cf36-40ca-9a70-a91004bd3c1f 32 fields · synced May 30, 2026
- FDA UDI f067d3de-9182-4ec4-95cd-27334b25319c 32 fields · synced May 30, 2026
- EUDAMED be5a36d7-20d8-4109-8901-4c217f0314cd 61 fields · synced Jul 8, 2026
- EUDAMED 5235c083-7c0d-4c2c-b4e8-6367bd610b5a 61 fields · synced Jul 8, 2026
- EUDAMED bd1e6a9c-93c5-4c7e-ad13-4aafa1cbed40 61 fields · synced Jul 8, 2026