BEUDAMED

Authorized Representative 🇩🇪 Germany Active

Penumbra Europe GmbH

SRN: DE-AR-000004997 · Am Borsigturm 44, 13507 Berlin, Germany

View on EUDAMED

Manufacturers

1

Devices

14

Certificates

12

PRRCs

1

Basic Information

Address: Am Borsigturm 44, 13507 Berlin, Germany
Email: [email protected]
VAT Number: DE 815054796
Trade Register: Handelsregister
EORI: DE6979513

Non-EU Manufacturers

Name	Country	SRN
Penumbra, Inc.	🇺🇸 United States	US-MF-000008514

Manufacturers

Penumbra, Inc.

🇺🇸 United States·14 Basic UDI-DIs·14 Devices·National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), National Standards Authority of Ireland (NSAI), and National Standards Authority of Ireland (NSAI)

Certificates

Type	Number	Manufacturer	Notified Body	Status
MDD Annex II Section 4	252.949	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.901	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II (excluding section 4)	252.885	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.934	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.711	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.807	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.806	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.761	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.943	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.969	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.932	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)
MDD Annex II Section 4	252.962	Penumbra, Inc.	National Standards Authority of Ireland (NSAI)

Devices

Penumbra Smart Coil Detachment Handle

EU MDR · Eu Md Class 1 ·Penumbra, Inc.·On the market·32 countries

Penumbra ENGINE Canister – Penumbra System

EU MDR · Eu Md Class 1 ·Penumbra, Inc.·On the market·32 countries

Penumbra Smart Coil Wave Extra Soft, 1 mm x 1 cm

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

Ruby Extra Soft, 2mm x 1 cm

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

Penumbra ENGINE Pump

EU MDD · Eu Md Class 2a ·Penumbra, Inc.·On the market·32 countries

POD, 3 mm x 20 cm

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

Reperfusion Catheter 3MAX, 153 cm

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

PX SLIM 150 cm, 45° tip

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

Coil 400 Complex Standard, 7mm x 20 cm

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

Neuron Delivery Catheter (115cm/12cm)

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

Aspiration Catheter 3

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

4MAX DDC - Distal Delivery Catheter, 130 cm

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

6F Benchmark 95cm Straight

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries

Artemis Neuro Evacuation Device 1.5 mm

EU MDD · Eu Md Class 3 ·Penumbra, Inc.·On the market·32 countries