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Delphinus Sequr Breast Interface
EUDAMEDClass I (EU MDR)
Ref 900-00010Model 04-02
Identity
- Trade Name
- Delphinus Sequr Breast Interface EUDAMED
- Device Name
- Aquaflex Gel Pad EUDAMED
- Model / Reference
- 04-02 EUDAMED900-00010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20855683006573 EUDAMED
- Basic UDI-DI
- 085568300604000H8 EUDAMED
- Unit of Use DI
- 10855683006576 EUDAMED
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Delphinus Sequr Breast Interface by Parker Laboratories, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085568300604000H8 | Class I | Active |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (1)
- EUDAMED 0abecc2b-d405-43b1-9483-9c1a8205d9dc 61 fields · synced Jun 19, 2026