← Back to catalogue
gigazyme
EUDAMEDClass I (EU MDR)
Ref 70003409Ref 70003410Ref 70003411Ref 70003408
Identity
- Trade Name
- gigazyme EUDAMEDgigazyme X-tra EUDAMED
- Device Name
- gigazyme EUDAMEDgigazyme X-tra EUDAMED
- Model / Reference
- 70003409 EUDAMED70003410 EUDAMED70003411 EUDAMED70003408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651984282 EUDAMED04032651984305 EUDAMED04032651984329 EUDAMED04032651984275 EUDAMED
- Basic UDI-DI
- 4032651BSC00000056AM EUDAMED4032651BSC00000039AM EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMEDZ12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Medical device disinfection agent
gigazyme by Schülke & Mayr GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection agent.
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class I
- Instru Zym — Laboratorium Dr. Deppe GmbH · Class I
- Your First Enzymatic & Non-Enzymatic Sponges — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Rapidzyme PR — Novapharm Research (Australia) Pty Ltd · Class IIb
- Olie Medical Performance Enzymatic 5 — Amity Limited · Class I
- Coltene Biosonic UC40 — Topdental (Products) Ltd · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4032651BSC00000056AM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (4)
- EUDAMED 34d6c894-f43b-4ef1-9f5b-86b8325b63c7 61 fields · synced Oct 6, 2026
- EUDAMED 34e2858a-3f0b-4ba5-8bfc-088ee2ff8d63 61 fields · synced May 17, 2026
- EUDAMED f9555b2f-8b45-4704-a3b8-94748978ee75 61 fields · synced May 18, 2026
- EUDAMED 1bec11f9-29bd-4317-8321-a827e56f9299 61 fields · synced May 18, 2026