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Blue Pecker Plus
EUDAMEDClass IIa (EU MDR)
Ref SWVP-13H11ARef SWVP-11H11ARef SWVP-13H11Ref SWVP-11H11
Identity
- Trade Name
- Blue Pecker Plus EUDAMED
- Device Name
- Blue Pecker Plus EUDAMED
- Model / Reference
- SWVP-13H11A EUDAMEDSWVP-11H11A EUDAMEDSWVP-13H11 EUDAMEDSWVP-11H11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272563839 EUDAMED08809272562832 EUDAMED08809272562825 EUDAMED08809272562818 EUDAMED
- Basic UDI-DI
- B-08809272563839 EUDAMEDB-08809272562832 EUDAMEDB-08809272562825 EUDAMEDB-08809272562818 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intraosseous infusion kit
Blue Pecker Plus by Seawon Meditech Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809272563839 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Seawon Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED a2887031-23f7-459e-b435-36dc0c635bee 61 fields · synced Aug 4, 2026
- EUDAMED a6e26f7c-210e-4c62-8af0-41d274aad992 61 fields · synced May 17, 2026
- EUDAMED de4fde10-a57c-4cb6-9170-b00c6d801b0d 61 fields · synced May 17, 2026
- EUDAMED f05fb42d-ab69-471e-8ec8-c4b562cf10d2 61 fields · synced May 18, 2026