Question 1

What types of medical devices does IVF Hartmann AG manufacture?

Accepted Answer

IVF Hartmann AG specializes in two primary categories: single-use ophthalmic surgical procedure kits (for eye surgeries) and reusable waterproof bathing covers for casts or bandages. Additionally, they produce sterile quick dressings, gel compresses, and fixation rolls, all designed for wound care applications. These products are tailored for clinical and patient use in sterile or protected environments.

Question 2

Where is IVF Hartmann AG based?

Accepted Answer

IVF Hartmann AG is based in Switzerland, as indicated by the country designation (CH). This location places the company within the European regulatory framework, which governs its medical device offerings.

Question 3

Which regulatory registries list IVF Hartmann AG’s devices?

Accepted Answer

IVF Hartmann AG’s medical devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used for transparency and traceability of devices authorized under EU regulations.

Question 4

How are IVF Hartmann AG’s devices classified under medical device regulations?

Accepted Answer

All of IVF Hartmann AG’s listed devices fall under Class I classification. This classification applies to low-risk devices, such as single-use surgical kits, waterproof bandage covers, and sterile dressings, which typically pose minimal risk to patients when used as intended.

Device	Model / Reference	Registries	Class	Status
DermaPlast SPARABLANC TRANSPARENT	521340	EUDAMED	Class I	Active
Conviva Protect+	528000	EUDAMED	Class I	Active
DermaPlast SPARABLANC TRANSPARENT	521330	EUDAMED	Class I	Active
Apoteket Sterile quick dressing waterproof	532585	EUDAMED	Class I	Active
DermaPlast SPARABLANC TEXTIL	521011	EUDAMED	Class I	Active
Apoteket Apoteket Fixation roll	532000	EUDAMED	Class I	Active
DermaPlast SPARABLANC TRANSPARENT	521311	EUDAMED	Class I	Active
Apoteket Sterile quick dressing waterproof	532586	EUDAMED	Class I	Active
DermaPlast SPARABLANC TRANSPARENT	521321	EUDAMED	Class I	Active
DermaPlast SPARABLANC TEXTIL	521021	EUDAMED	Class I	Active
DermaPlast Compress Gel	218700	EUDAMED	Class I	Active
M-Plast Gel compresses	297020	EUDAMED	Class I	Active
Patient BE	990587	EUDAMED	Class I	Active
DermaPlast Compress Gel	218720	EUDAMED	Class I	Active
TRAUMA BANDAGE 20cm	831275	EUDAMEDFDA UDI	Class I	Active
M-Plast Cooling bandage	589005	EUDAMED	Class I	Active
DermaPlast Compress Protect	550201	EUDAMED	Class I	Active
DermaPlast Combifix	831150	EUDAMED	Class I	Active
Cellodent	263010	EUDAMED	Class I	Active
DermaPlast Compress Protect	550211	EUDAMED	Class I	Active
TRAUMA BANDAGE 10cm	831273	EUDAMEDFDA UDI	Class I	Active
Finger sleeve	833350	EUDAMED	Class I	Active
DermaPlast Combifix	831140	EUDAMED	Class I	Active
ENT set	990574	EUDAMED	Class I	Active
DermaPlast Compress Gel	218710	EUDAMED	Class I	Active
Armtraggurt	832410	EUDAMED	Class I	Active
Arm sling	832470	EUDAMED	Class I	Active
DermaPlast Compress Plus	550311	EUDAMED	Class I	Active
DermaPlast plaster case	553240	EUDAMED	Class I	Active
DermaPlast plaster case	500027	EUDAMED	Class I	Active
Flawa Blood Stop	601610	EUDAMED	Class I	Active
Patient set	990500	EUDAMED	Class I	Active
Arm sling	832420	EUDAMED	Class I	Active
DermaPlast Compress Plus	550321	EUDAMED	Class I	Active
Patient kit L	990538	EUDAMED	Class I	Active
Conviva Hydro+	528050	EUDAMED	Class I	Active
TRAUMA BANDAGE 15cm	831274	EUDAMEDFDA UDI	Class I	Active
DermaPlast plaster case	831510	EUDAMED	Class I	Active
DermaPlast plaster case	553260	EUDAMED	Class I	Active
Patient kit M	990537	EUDAMED	Class I	Active
Patient kit XL	990539	EUDAMED	Class I	Active
DermaPlast Alginat	601510	EUDAMED	Class I	Active
DermaPlast ACTIVE Coolfix	522013	EUDAMED	Class I	Active
DermaPlast plaster case	831500	EUDAMED	Class I	Active
Finger sleeve	833340	EUDAMED	Class I	Active

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