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DEWIN Micromanipulation pipettes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9228-30-5.5Model D-ICSI, D-HOLD, D-BIOX, D-DENU, D-HATC, D-HPZD
Identity
- Trade Name
- DEWIN Micromanipulation pipettes EUDAMEDDEWIN FDA UDI
- Generic Name
- User-induced micropipette FDA UDI
- Device Name
- DEWIN Micromanipulation pipettes EUDAMEDMicromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitro cell manipulation.The D-HPZD pipette is used to cut an opening on the zona pellucida mechanically to enable assisted hatching and/or embryo biopsy. FDA UDI
- Model / Reference
- D-ICSI, D-HOLD, D-BIOX, D-DENU, D-HATC, D-HPZD EUDAMED9228-30-5.5 EUDAMEDD-HPZD FDA UDI
- Description
- Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitro cell manipulation.The D-HPZD pipette is used to cut an opening on the zona pellucida mechanically to enable assisted hatching and/or embryo biopsy. FDA UDI
Identifiers
- Catalog Number
- 9228-30-5.5 FDA UDI
- Primary DI / UDI-DI
- 16972962311962 EUDAMEDFDA UDI
- Basic UDI-DI
- 697296231Micropipette7V EUDAMED
- FDA Product Code
- PUC FDA UDI
- EMDN Code
- U0802030108 PZD PIPETTES 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
- Germany 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
DEWIN Micromanipulation pipettes by DonneVie Medical Technology(Shanghai)Co.Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697296231Micropipette7V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DonneVie Medical Technology (Shanghai) Co., Ltd
- EUDAMED SRN
- CN-MF-000049254
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED c04d2ba3-f4a9-4d1e-b9f9-49e73a0481e4 61 fields · synced Oct 6, 2026
- FDA UDI d67495e0-3f94-443e-bff8-f27b4ffabaa4 35 fields · synced May 29, 2026