Manufacturer
Who makes
Crespine Gel.
BioPolymer in Dümmer, Germany, manufactures Crespine Gel. Here you can find the company details and the existing information on certification and quality assurance.
Manufacturing
BioPolymer GmbH & Co. KG
Dümmer · Germany
Manufacturer addressWalsmühler Str. 18
19073 Dümmer
- Company established
- 2001
- Crespine Gel since
- 2008
Crespine Gel is manufactured by BioPolymer GmbH & Co. KG in Dümmer, Germany — Walsmühler Str. 18, 19073 Dümmer. The company has existed since 2001; the product has been on the market since 2008.
netHEAVEN GmbH is a distributor, not the manufacturer within the meaning of Regulation (EU) 2017/745. Responsibility for the intended purpose, the clinical evaluation and conformity rests with the manufacturer.
Certification
| Classification | Class III medical device |
|---|---|
| Legal framework | Directive 93/42/EEC, conformity assessment under Annex II |
| Notified body | CE Certiso Kft. (NB 2409) |
| Quality management | ISO 13485:2016, certificate 145211-23-12-15 |
| SRN | DE-MF-000004926 |
| Instructions for use | DE, EN, FR, IT, ES, PT · version 05.2019 |
Transition to the MDR: the application under Regulation (EU) 2017/745 is with the notified body and the agreement under Regulation (EU) 2023/607 has been concluded. Transitional validity runs until 2027-12-31.
Quality assurance
The hyaluronan is produced by biofermentation, not from animal material. Every batch is tested for endotoxins by an independent laboratory. We provide the declaration of conformity and the certificates to healthcare professionals on request.
For healthcare professionals
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