📊 2,000+ Krankenhäuser in Deutschland | EU MDR 2017/745 konformer Markt | CE-Kennzeichnung erforderlich | DHL Express nach Deutschland: 4–5 Werktage
Fizza Surgical liefert CE-konforme chirurgische Instrumente nach Deutschland — an Krankenhäuser, Medizinhandel und Einkaufskooperationen. Unsere Instrumente sind nach ISO 13485:2016 zertifiziert, CE-konform gemäß EU MDR 2017/745 und werden aus 316L Edelstahl in Sialkot, Pakistan gefertigt.
Fizza Surgical exports CE-certified surgical instruments to German hospitals and medical distributors. All instruments comply with EU MDR 2017/745 and ISO 13485:2016. We provide complete regulatory documentation in English and can support German-language labeling requirements.
EU MDR Compliance for German Market
- CE marking under EU MDR 2017/745 — required for all surgical instruments placed on the German/EU market
- EC Declaration of Conformity — provided with all orders
- ISO 13485:2016 certificate — third-party audited quality management
- Technical File — maintained by Fizza Surgical as manufacturer, available to competent authorities on request
- UDI (Unique Device Identification) — implemented for applicable product categories
Product Categories for German Hospitals
Complete range covering: Allgemeinchirurgie (general surgery sets), Gynäkologie (gynaecology instruments), HNO (ENT instruments), Orthopädie (orthopedic instruments), Zahnmedizin (dental instruments), Laparoskopie (laparoscopic instruments), and Anleitung (laryngoscopes).
Shipping to Germany
DHL Express from Sialkot to Germany: 4–5 Werktage (business days) door-to-door. Import duty from Pakistan: 0% under EU GSP (Pakistan is an EU GSP beneficiary country for HS 9018 instruments). Full EU customs documentation provided.
- ISO 13485:2016 — International quality management for medical devices
- CE marking under EU MDR 2017/745 — European conformity
- 316L stainless steel — Full material test certificates on request
- Manufacturing since 1980 — Sialkot, Pakistan (global surgical instrument capital)
Contact Fizza Surgical for German hospital pricing, EU MDR documentation, or sample evaluation. WhatsApp: +92 333 843 3925 | Email: [email protected]
Frequently Asked Questions
What is your minimum order quantity (MOQ) for Germany?
How long does shipping take to Germany?
Do you support BfArM registration?
Can I get free samples before placing a bulk order?
What payment methods and import duties apply?
Are your instruments made of medical-grade stainless steel?
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