Spiegelberg GmbH & Co. KG
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000000008 FEI 3002108226
- Devices
- 37
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
EU certificates
4 of 4 in force.
Market reach
- European Union
- EUDAMED actor, 4 certificates
- United States
- FDA FEI, FDA recalls
What Spiegelberg GmbH & Co. KG makes
Spiegelberg GmbH & Co. KG manufactures medical devices for neurosurgical and intracranial pressure monitoring, including external ventricular drainage sets with plates and clamps, subdural and ventricular drainage catheters, parenchymal probes, and tunneling probes. Their portfolio also covers intracranial pressure monitors, cranial bolts for catheter fixation, and specialized sondes and probes designed for cerebrospinal fluid management.
The company’s devices fall under EU device classes I, IIa, and III, reflecting varying regulatory requirements for safety and performance. These products are registered in the EU’s eudamed database, and the manufacturer is based in Germany.
Catalogue
Search and filter all 37 devicesCompany details
- EUDAMED SRN
- DE-MF-000000008
- FDA FEI number
- 3002108226
- EU VAT number
- DE118251415
- EUDAMED status
- Active
- EUDAMED registered name
- Spiegelberg GmbH & Co. KG
- Registered address
- 4, Tempowerkring, 21079, Hamburg, Germany
- Website
- www.spiegelberg.de
- [email protected]
- Phone
- +49 40 790 178 0
- PRRC contact
- Rafiye Kilic
EUDAMED certificates
4 certificates4 valid, 0 expiredMDR 4next expiry 20 Mar 2029
DQS Medizinprodukte GmbH 0297 4 certificates
- 1000265951 Active
Technical documentation EU MDR
- Issued
- 23 Oct 2025
- Expires
- 22 Oct 2030
- 1000216002 Active
Technical documentation EU MDR
- Issued
- 13 Mar 2025
- Expires
- 12 Mar 2030
- 1000210544 Active
Technical documentation EU MDR
- Issued
- 3 Mar 2025
- Expires
- 20 Mar 2029
- 1000265927 Active
Quality management system EU MDR
- Issued
- 23 Oct 2025
- Expires
- 20 Mar 2029
FDA recalls
FDA recall records list 1 recall initiated by Spiegelberg GmbH & Co. KG, initiated on 2009-12-29. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 29 Dec 2009 Z-2888-2016 Class II Terminated In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.
From the company website
Spiegelberg is one of the leading providers of medical technology. The range includes innovative products such as: probes, catheters, EVD sets, shunt catheters, ICP monitors and accessories. Spiegelberg was founded in 1986 in Hamburg and today serves customers in more than 40 countries worldwide.
Frequently asked questions
How many devices does Spiegelberg GmbH & Co. KG have in the registry?
The registry currently lists 37 devices for Spiegelberg GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spiegelberg GmbH & Co. KG's devices?
Among its 37 most recently registered devices, Spiegelberg GmbH & Co. KG has devices listed in EUDAMED (37 devices).
What risk classes do Spiegelberg GmbH & Co. KG's devices fall under?
Among its 37 most recently registered devices, the classes recorded for Spiegelberg GmbH & Co. KG's devices are Class I, Class IIa and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Spiegelberg GmbH & Co. KG?
FDA recall records list 1 recall initiated by Spiegelberg GmbH & Co. KG, the most recent initiated on 29 Dec 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Spiegelberg GmbH & Co. KG?
EUDAMED lists 4 certificates for Spiegelberg GmbH & Co. KG (technical documentation; quality management system) under MDR. 4 are recorded with the status issued. The most recent was issued on 23 Oct 2025.
What are the newest devices from Spiegelberg GmbH & Co. KG in the registry?
The most recently registered devices listed for Spiegelberg GmbH & Co. KG include External Ventricular Drainage Kit Light, External Ventricular Drainage Kit, External Ventricular Drainage Set with Plate and Clamp and Silverline® Subdural Drainage Catheter 8F.