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Percutaneous Insertion Kit (scalpel +4 more)
EUDAMEDClass IIa (EU MDR)
Ref 701047384Model PIK 100
Identity
- Trade Name
- Percutaneous Insertion Kit (scalpel, puncture needle, guidewire 100 cm, dilators, syringe) EUDAMED
- Device Name
- Percutaneous Insertion Kit (scalpel, puncture needle, guidewire 100 cm, dilators, syringe) EUDAMED
- Model / Reference
- PIK 100 EUDAMED701047384 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04037691519883 EUDAMED
- Basic UDI-DI
- B-04037691519883 EUDAMED
- EMDN Code
- C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- Models / Variants
- scalpel EUDAMEDpuncture needle EUDAMEDguidewire 100 cm EUDAMEDdilators EUDAMEDsyringe 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: Surgical bulldog clamp, single-use
Percutaneous Insertion Kit (scalpel +4 more) by Maquet Cardiopulmonary GmbH — Class IIa — MDD — listed in EUDAMED — 5 models — regulatory data on deviCERTS
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Also classified as Surgical bulldog clamp, single-use.
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- BM-BID-I30P — BrosMed Medical Co., Ltd. · Class I
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-04037691519883 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (1)
- EUDAMED 7e6cd5e7-4a99-4da8-bb10-e00d741f0e16 61 fields · synced Jul 16, 2026