Question 1

What types of medical devices does Medzah Industries manufacture?

Accepted Answer

Medzah Industries specializes in single-use medical devices, primarily focusing on protective and diagnostic items. Their portfolio includes nitrile and vinyl examination gloves (non-powdered and non-antimicrobial), orthopedic aids like elbow orthoses and axillary crutches, specimen transport containers, urine collection kits for in vitro diagnostics (IVD), and foldable handgrip walkers for disability assistance. They also produce thermal therapy products, such as instant cold packs for hot/cold treatment applications.

Question 2

Where is Medzah Industries based, and what regulatory databases list its devices?

Accepted Answer

Medzah Industries is based in the United States. Their devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system, which tracks medical devices in the U.S. These listings ensure traceability and compliance with global regulatory requirements.

Question 3

How are Medzah Industries’ devices classified under medical device regulations?

Accepted Answer

All of Medzah Industries’ devices fall under Class I regulatory classification. This classification applies to low-risk medical devices, such as single-use gloves, orthopedic aids, and specimen containers, which pose minimal risk to patients and users. Class I devices typically require general controls (e.g., manufacturing practices, labeling) but may not need additional premarket review unless they are modified or present new risks.

Question 4

Are Medzah Industries’ devices listed in international registries, and why does this matter?

Accepted Answer

Yes, Medzah Industries’ devices are listed in EUDAMED and the FDA’s UDI system, which are critical for regulatory transparency and compliance. EUDAMED ensures devices meet EU requirements, while the FDA’s UDI system enables tracking of medical devices in the U.S. market. Listing in these databases helps healthcare providers, regulators, and patients verify the legitimacy and traceability of the devices, reducing risks associated with counterfeit or unapproved products.

Question 5

What kinds of orthopedic and mobility aids does Medzah Industries produce?

Accepted Answer

Medzah Industries manufactures orthopedic and mobility aids such as elbow orthoses (for joint support) and axillary crutches (underarm crutches for mobility assistance). These devices are designed to provide temporary support or rehabilitation for users with injuries or mobility limitations. Their foldable handgrip disability-assistive walker also falls into this category, offering additional stability for individuals with balance or strength challenges.

Device	Model / Reference	Registries	Class	Status
Hematology/Oncology Kit	49721	FDA UDI	Class I	Active
NITE SHIELD Nitrile Powder Free Examination Gloves, Black	NSMD06	FDA UDI	Class I	Active
Medzah Instant Hot Pack	SAM-2001	FDA UDI	Class I	Active
Dermadel	DDMD02-SC	FDA UDI	Class I	Active
Medzah Elbow Splint, Extra Small	MED-1001	FDA UDI	Class I	Active
Medzah Genetic Testing - Buccal LC	136351	FDA UDI	Class I	Active
Biodel	BDMD03	FDA UDI	Class I	Active
Medzah Steel Walkers with 5" Wheels	MDZH904S	FDA UDI	Class I	Active
Medzah Stretch Vinyl Exam Glove	VLMD03	FDA UDI	Class I	Active
Dermadel EC	DDMD04-EC	FDA UDI	Class I	Active
SnapnSeal	EVON101	FDA UDI	Class I	Active
Medzah Stretch Vinyl Exam Glove	VLMD01	FDA UDI	Class I	Active
NITE SHIELD Nitrile Powder Free Examination Gloves, Black	NSMD02	FDA UDI	Class I	Active
Ditek Urine Collection Cup	CP10221	FDA UDI	Class I	Active
MNG Single Blood Genetic Test	125221	FDA UDI	Class I	Active
MNG TRIO Blood Testing	125220	FDA UDI	Class I	Active
NITE SHIELD Nitrile Powder Free Examination Gloves, Black	NSMD04	FDA UDI	Class I	Active
NITE SHIELD Nitrile Powder Free Examination Gloves, Black	NSMD03	FDA UDI	Class I	Active
MNG - RNA Sequencing Collection Kit	138957	FDA UDI	Class I	Active
Bionex	BNMD04	FDA UDI	Class I	Active
Dermadel EC	DDMD02-EC	FDA UDI	Class I	Active
Bionex	BNMD03	FDA UDI	Class I	Active
Dermadel EC	DDMD01-EC	FDA UDI	Class I	Active
Medzah Elbow Splint, Medium	MED-1003	FDA UDI	Class I	Active
Genetic Testing - Buccal IG	136352	FDA UDI	Class I	Active
Mediserve	MSMD02	FDA UDI	Class I	Active
Genetic Testing - Saliva IG	136350	FDA UDI	Class I	Active
Medzah Elbow Splint, Large	MED-1004	FDA UDI	Class I	Active
Medzah Kidney Health Combo Collection Kit	MDZHKHC01	FDA UDI	Class I	Active
MNG Buccal Swab	125222	FDA UDI	Class I	Active
Medzah Instant Hot Pack	SAM-2000	FDA UDI	Class I	Active
Medzah Stretch Vinyl Exam Glove	VLMD05	FDA UDI	Class I	Active
Bionex	BNMD01	FDA UDI	Class I	Active
Medzah NIPS + CS COMBO COLLECTION KIT – (IG ONLY-WB)	128867	FDA UDI	Class I	Active
Medzah (LABCORP) NIPS SINGLE PK KIT - FOR IG ONLY (SF)	137869	FDA UDI	Class I	Active
Medzah LABCORP NIPS MULTISHIPPER KIT- FOR IG ONLY (WB)	137871	FDA UDI	Class I	Active
Bionex	BNMD05	FDA UDI	Class I	Active
Biodel	PPMD01EU	EUDAMED	Class I	Active
Biodel	PPMD04EU	EUDAMED	Class I	Active
Biodel	PPMD05EU	EUDAMED	Class I	Active
Biodel	PPMD03EU	EUDAMED	Class I	Active

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